The Life Sciences Report: Jason, you have commented that many investors get angry when the small biotech companies they own raise equity capital. Your response is, would you rather see the companies go bankrupt? When did dilution get to be a crime?
Jason Napodano: It's baffling to me, considering the alternative is bankruptcy. I think investors lose sight of the fact that developing pharmaceutical products is incredibly expensive, and that almost all publicly traded companies in the biotech sector, except maybe the top 10, burn cash each quarter. The reason these companies become public in the first place is so they can continue their development plans, and that process involves raising new capital from new investors.
TLSR: When should an investor get concerned about a company going back to the market for more capital?
JN: Where you should have concern is when a company raises cash and then comes back to the market having burned that cash without making progress. It's totally understandable when investors get frustrated with companies that raise cash poorly, either with low-quality investors, or at the wrong time, or the wrong way. My advice is, if the biotech company you own raises cash, as long as it is putting that cash to effective use—moving products forward, expanding the sales force, acquiring a new drug, launching a new product, etc.—then you should be OK with that. Ultimately, it comes down to management.
TLSR: People who loan money to small biotech companies expect that debt to be returned as equity later. Should debt concern investors, even if they're not being diluted?
JN: I'm not a fan of debt for precommercial companies because they often have to give too much in collateral, and they have to spend too much to service the debt, even though they have no cash flows. Oftentimes debt comes with equity components, like warrants and convertible notes, so the terms are often not great.
I have no problem with a commercial organization issuing debt as long as it's funding the commercial enterprise and management can use the revenues facilitated by that debt to pay it back. A perfect example of that is Depomed Inc. (DEPO:NASDAQ), which issued almost $800 million ($800M) in debt over the past several quarters, but acquired a drug, Nucynta (tapentadol), an opioid, that most analysts believe will generate between $500M and $1 billion ($1B) in annual sales. My advice to investors is to avoid precommercial biotech companies issuing debt, but have no fear about cash-flow-positive commercial organizations issuing debt.
TLSR: Do you feel like small- and especially micro-cap investors should think more like venture capitalists? Should they count on staging investments as companies raise capital the way venture capitalists do, to keep their proportional equity ownership?
JN: I think small- and micro-cap biotech investors should understand that some of their investments will fail, and some will succeed. The small-cap biotechs that succeed can triple and quadruple. If you're a shareholder in a successful company, you may have bought stock on the open market or participated in a financing to fund a Phase 2 trial. If that Phase 2 trial was successful, the company will need money to fund a Phase 3 trial. If you liked it based on the Phase 2, then it's OK to put more money into it for a Phase 3. That's what venture capitalists do: They will seed a proof-of-concept study, and if it works, they take it to the next level—to a valuation inflection. That's how you make money.
TLSR: You mentioned the failures. We wish we never got into those names, don't we?
JN: Again, you are going to have investments that fail. The best strategy is to try to cut your losers quickly. You're going to have investments that succeed, and the best strategy is to let those winners ride. Most novice biotech investors do the opposite. They cut their winners quickly and let their losers ride.
TLSR: Would you talk about some ideas?
JN: Sure. Can-Fite BioPharma Ltd. (CANF:NYSE.MKT) is an Israeli company that's interesting because of the big potential in its clinical pipeline and its incredibly cheap valuation. There are two clinical-stage candidates, CF101 (piclidenoson) for psoriasis and rheumatoid arthritis (RA) and CF102 for liver cancer and nonalcoholic steatohepatitis (NASH). Both should be in Phase 3 in 2016.
The interesting thing about CF101 is that it is a targeted approach—a personalized medicine approach for psoriasis and RA. It is based on biomarker expression of an A3 adenosine receptor (A3AR), which the company has found to be expressed at relatively low levels in healthy cells but overexpressed in a number of inflammatory diseases, such as RA and psoriasis. CF101 is designed to knock out A3AR through a cellular cascade that inhibits inflammatory cytokine production and mutes flare-ups of the disease, whether RA or psoriasis. CF101 is more specific and targeted than a broad-spectrum systemic therapy like a nonsteroidal anti-inflammatory (NSAID), or a steroid, or methotrexate. It is also safer than more powerful biologic drugs that are incredibly expensive and have significant side effects. I think there's an interesting opportunity for CF101 in both RA and psoriasis.
"Rexahn Pharmaceuticals Inc. has three very interesting, early-stage anticancer drugs, and a sound development program."
CF102 is a specific A3AR agonist, and has a potent effect on liver cancer. It has been granted orphan drug status in Europe and fast-track status in the U.S. Can-Fite is going after a specific population of liver cancer patients who have little or no other treatment options—they have failed standard of care and are not seeing a response to Nexavar (sorafenib; Bayer AG (BAYRY:OTCMKTS; BAYN:XETRA)), which is essentially the last-line therapy. In a Phase 2 clinical trial, CF102 showed encouraging results in these high-risk, low-option patients, and that is very interesting. CF102 is in Phase 2 for liver cancer and is soon to be in Phase 3.
The other interesting thing is that the company just released data in NASH. It's preclinical data, but they seem to show that CF102 may have utility earlier on in liver disease pathology in things like nonalcoholic fatty liver disease and NASH. That will be moving forward in 2016 as well. In Can-Fite we have big markets and a very small valuation, and together I think that creates a compelling opportunity for investors.
TLSR: Looking at Can-Fite's clinical development activity at ClinicalTrials.gov, I noted 13 studies in progress, recruiting, or completed. That's a lot of activity for a company with a low valuation of $31M. Back in mid-September, when the company announced it had received fast-track designation for CF102 in hepatocellular carcinoma, the stock more than doubled. Right now institutional investors can't buy this stock, so I'm thinking shares are in the hands of small hedge funds and day traders. What is your take on the investor base?
JN: Can-Fite is not well owned on the institutional side, and I think that's due to a combination of the company being both foreign and small. I think the majority of the action is coming from the retail-investor side right now.
But the data look encouraging enough that I think Can-Fite could be well owned in the future. It has a good pedigree with its science, its pipeline and its potential market opportunities. When you talk about RA, psoriasis, liver cancer and NASH, those are big pharma-type markets. If the company can reproduce its encouraging data in later-stage trials, you'll start to see this name get onto the institutional and big pharma radar in 2016.
TLSR: Can-Fite had about $14M on its balance sheet at the end of September, and in October it raised $4.8M, which means it has somewhere just under $19M in cash right now. How long can that fund operations?
JN: The company doesn't burn much cash—only about $2–2.5M a quarter. At that rate, there are 18 to 24 months of cash on the books. But it will be starting Phase 3 trials in 2016. I think Can-Fite has enough cash to get through 2016, start these clinical programs, and start talking with partners about rights to these drugs, either outside or inside the U.S.
"Can-Fire BioPharma Ltd. had big potential in its clinical pipeline and an incredibly cheap valuation."
Certainly, opportunities in liver cancer and NASH are tremendous in Asia. If a company wanted the rights to CF102 in China, Korea or Japan, I think that could bring in nondilutive cash in 2016. These don't have to be large deals to be effective financing vehicles for the company. If it could bring in a few million dollars by out-licensing the rights to a drug to Korea, that might be enough to finish a Phase 3 study or start another Phase 3 study. I think Can-Fite has more options because of the size of the markets it's going after, and the stages of its drugs, than its market cap would allude to.
TLSR: Jason, immunotherapy, especially in oncology, is a hot topic right now, and investors are head-over-heels for this category. You have an interesting name with a very low valuation under coverage, and it is developing a therapeutic immunization. Tell me about that.
JN: Sure. BriaCell Therapeutics Corp. (BCT:TSX.V) is a Canadian company—another very small company. I'm intrigued by what it's doing with a therapeutic cancer vaccine called BriaVax for women with late-stage metastatic breast cancer. This is very difficult to treat, there are limited treatment options and, unfortunately, it's a large population.
"Avoid precommercial biotech companies issuing debt, but have no fear about cash-flow-positive commercial organizations issuing debt."
Therapeutic cancer vaccines have come a long way since Dendreon Corp.'s (DNDN:NASDAQ) failure with Provenge (sipuleucel-T) in prostate cancer. I think BriaCell really has something here. BriaVax is a proprietary whole cell tumor vaccine that was isolated from a chest-wall lesion of a woman with metastatic breast cancer many years ago. It's genetically modified to release granulocyte macrophage colony-stimulating factor (GM-CSF), which is a highly potent immunostimulatory molecule designed to induce tumor immunogenicity. Essentially, you are presenting the patient with a radiated tumor antigen, and that cell is then producing an immunostimulatory molecule that essentially kicks the body into high gear by exciting and extending the T-cell response to the antigen.
BriaCell has gotten encouraging results so far, but only in 18 women, so we don't have an enormous amount of data. But, generally speaking, these women have a life expectancy of only about a year. Of the 18 patients treated with BriaVax, several have made it out to 34, 36, even 40 months, and that's impressive. The company is getting ready to conduct another Phase 2 study in 2016.
TLSR: This is an allogeneic therapeutic vaccine, and as such, it would be an off-the-shelf agent, unlike Provenge, which had to be manufactured for each patient individually. That makes BriaVax interesting from a cost-of-goods-sold perspective. Are we talking about a single antigen being presented to the patient's immune system?
JN: No. The whole tumor cell is presenting multiple antigens to the body. That is the exciting thing. BriaVax is not specific to estrogen receptor-positive or HER2-positive tumors. It is a whole cell tumor vaccine that is stimulated with GM-CSF to generate the immune response. Results have been impressive.
TLSR: There's a companion diagnostic being developed for this therapeutic immunization. The fact that the company can narrow down its patient population to a very favorable group for treatment holds potential for exciting p-values in the clinical trial, doesn't it?
JN: That's right. Personalized medicine—being able to target a patient's cancer more specifically—is an important concept and is starting to gain traction. I think personalized medicine and orphan drugs are the two biggest trends in small-cap biotech right now. The more you know about a patient and how your drugs work for that patient's disease is important not just to the patient, but also to investors. You might think that if only 50% of patients have a biomarker, the pharma company has cut the market in half. That's not true. The more specific you get, the higher price you can charge for a targeted drug. The market opportunities for personalized medicines, even in orphan indications, are tremendous. It represents a very big wave of drug development over the next several years.
TLSR: Jason, I note the company thinks BriaVax could become a maintenance therapy for the duration of the disease and possibly the patient's life. That's another interesting thought, isn't it?
JN: That idea adds to the potential size of this market. If this vaccine is found to prolong lives when used on a continuing basis, that just compounds the peak revenue potential for BriaVax. It is an exciting prospect for both patients and investors. Today this company has a market valuation of only about $20M. I think it could turn out very big. It's early-stage right now, but I really like the science. I think 2016 will prove very interesting for BriaCell if it can get its Phase 2 trial started and continue to show good data.
TLSR: How about another name?
JN: Actinium Pharmaceuticals Inc. (ATNM:NYSE.MKT) has a platform for acute myeloid leukemia (AML). It has two drugs, one of which is called Iomab-B, a conditioning regimen for really sick patients who may not be able to withstand standard conditioning for bone marrow transplant. The other drug, Actimab-A, is earlier stage, and is for elderly patients with AML who cannot tolerate standard of care.
Iomab-B, a radioactive iodine on a targeted monoclonal antibody, is in Phase 3, and it's like SEAL Team 6. It's a very interesting approach that delivers radiation to the bone marrow cells in a more targeted way to obliterate it without too much toxicity to the rest of the body, to avoid treatment-related mortality.
"If you liked a company based on Phase 2, then it's OK to put more money into it for Phase 3."
Standard conditioning often includes some combination of total body irradiation and chemotherapy, and is designed to knock out all of the bone marrow ahead of a hematopoietic stem cell bone marrow transplant. If you have AML, you are producing cancerous blast cells that are not maturing to full white blood cells. The goal is to wipe out the bone marrow, which wipes out all the cancerous cells. With a transplant of healthy marrow from a matched donor, you could potentially cure the AML. In fact, AML is a curable cancer if the treatment option works.
However, standard conditioning is difficult to tolerate if you are elderly or you have comorbidities. It's a balancing act between enough radiation and enough chemotherapy to kill the bone marrow and prevent post-transplant graft rejection, but not so powerful that the patient dies.
TLSR: To be fair, a lot of small-cap biotechs are down from a year ago, but the market doesn't seem to have appreciated Actinium. With a $76M market cap it is large enough for some small-cap institutions to own, but it hasn't gotten Wall Street's attention. Is there an issue you can pinpoint?
JN: Actinium isn't the first company to develop a targeted monoclonal antibody with radioisotopes attached. There have been other drugs, and there have also been a lot of failures in the AML space. Pfizer Inc. (PFE:NYSE) had a drug that came with its Wyeth acquisition called Mylotarg (gemtuzumab ozogamicin), but it was pulled from the market. Bexxar (tositumomab + iodine I 131 tositumomab/ GlaxoSmithKline [GSK:NYSE]) was on the market and just didn't sell, so GSK discontinued it. Zevalin (ibritumomab tiuxetan) from Spectrum Pharmaceuticals Inc. (SPPI:NASDAQ) is still on the market but doesn't do very well. Each of these drugs has specific issues: They are too toxic, or they are too difficult to prepare, or they don't have centralized manufacturing.
Actinium's drug, and specifically Actimab, which is going to be a first-line therapy for elderly patients with AML, has certain advantages over these failed drugs. The market just hasn't caught on yet. It's possible the market is not giving Actinium enough credit for the changes it has made and the improvements in strategy. That would be a guess.
I really like Actinium's platform. I think radiolabeled immunotherapies have a place in the future treatment of hematological cancers. Everyone is excited about the chimeric antigen receptor (CAR) T cells being developed for leukemias and lymphomas by companies like Juno Therapeutics (JUNO:NASDAQ), Kite Pharma (KITE:NASDAQ) and bluebird bio Inc. (BLUE:NASDAQ), and these companies have market caps that are tenfold Actinium's just because of that excitement. But I think an effective, radiolabeled, targeted monoclonal antibody will be met with enthusiastic response by the oncologist community, as long as it has improvements and advantages over the older drugs. I think Actinium has the right strategy.
TLSR: Could you go to another name, please?
JN: I find RedHill Biopharma (RDHL:NASDAQ), another Israel-based company, to be interesting because of its specialty pharmaceutical model. It is focused on gastrointestinal (GI) diseases. That includes gastric cancer, but if you look at the company's pipeline, it's mostly targeting inflammatory GI conditions. There are three drugs currently in Phase 3, a partnered drug that could enter Phase 3, an approved drug in Europe, and a Phase 2 cancer drug. RedHill has a great pipeline.
I'll just talk about the Phase 3 drugs, which are all late-stage with catalysts on the horizon, and should be attractive to investors. The first is RHB-104 (clarithromycin + rifabutin + clofazimine), a triple antibiotic therapy for treatment of Crohn's disease, now in a 270-patient, double-blind, Phase 3 trial. This drug has the biggest sales potential of candidates in the RedHill pipeline.
TLSR: Antibiotics for Crohn's? We think of Crohn's disease as an autoimmune disease, not one caused by a bacteria.
JN: Crohn's is an inflammatory bowel disease that may be kicked off by infection with the Mycobacterium avium subspecies paratuberculosis (MAP) bacterium. The MAP infection manifests as Crohn's disease. The traditional way to treat Crohn's is with anti-inflammatory drugs, such as steroids, or with powerful biologics—the same biologics used to treat RA and psoriasis, quite coincidentally. RedHill is pioneering a new approach that could be complementary to those drugs, or could potentially stand alone. I like this approach because it's novel and is rooted in great science, published in the literature. The data so far show it's highly effective.
The second drug is RHB-105 (rifabutin + amoxicillin + omeprazole). It is another triple-combination product to treat Helicobacter pylori infection, this time using two antibiotics and one proton pump inhibitor (PPI), omeprazole, which is the active ingredient of Prilosec.
"The market opportunities for personalized medicines, even in orphan indications, are tremendous."
H. pylori infection is the proven culprit behind gastric ulcers. In fact, Barry Marshall and J. Robin Warren won the 2005 Nobel Prize for discovering the role H. pylori plays in inflammation of the stomach, or gastritis, and stomach ulcers. This, in my opinion, mirrors the path of MAP infection in Crohn's disease. Decades ago, no one believed bacteria were instigators of gastric ulcers, but now it is fact, and antibiotic and PPI therapy is the standard of care. Unfortunately, because antibiotics tend to lose efficacy over time as the H. pylori develops resistance, standard of care is only about 65% effective. RedHill is not reinventing the wheel here, but has developed a new formulation—an improved wheel.
The company has completed one Phase 3 trial that showed about 90% effectiveness. The therapy is in a second phase 3 now. It's essentially a no-brainer, in my opinion, that if this drug gets on the market, it will become the new standard of care because it will be priced the same as the current therapy. If you can go from 65% effectiveness to 90% effectiveness at the same cost and at the same dosing schedule, then I think RHB-105 will see a relatively rapid uptake in the GI community.
"You're going to have investments that succeed, and the best strategy is to let those winners ride."
The next drug is Bekinda (bimodal release ondansetron tablets), another GI disorder-focused product in Phase 3 for gastroenteritis. Gastroenteritis is colloquially known as stomach virus or stomach flu, even though it's not caused by the influenza virus. The Phase 3 data say Bekinda prevents nausea and vomiting in gastroenteritis, and prevents diarrhea in patients who have irritable bowel syndrome and diarrhea. Ondansetron has already been approved and is on the market to prevent nausea and vomiting with radiation or chemotherapy. The company has developed a new formulation targeted for patients with gastroenteritis most likely caused by the norovirus, which is actually called the vomiting bug in the U.K.
Again, it's a well-thought-out scientific approach, not reinventing the wheel but improving the treatment paradigm by coming at physicians with something they are familiar and comfortable with, that's effective, and that can be priced correctly with respect to the pharmacoeconomics of the disease.
TLSR: This is a lot of Phase 3 activity for a $146M market cap company. I note that RedHill has extensive institutional ownership, which should be some validation for the platform. Do you see it that way?
JN: Yes. The company has tremendous institutional ownership, and in addition to the Phase 3 programs it has a Phase 2 oncology platform for gastric cancer and other solid tumors. The pipeline is deep. It's also well capitalized, with $64M in cash and no debt, and has good management. RedHill is a name that investors should look at because it is focused on an interesting area of the market and has late-stage assets.
TLSR: In the past, you and I have talked about names that have been beaten down pretty hard. You keep your eye on some of these. Did you have one you might share today?
JN: Immune Pharmaceuticals Inc. (IMNP:NASDAQ) has been under some heavy selling pressure of late. Its market cap is down to about $22M, and I think that's because investors are frustrated with the lack of progress. The company spent the better part of last year working through quality issues with manufacturing of its lead product, a fully-human monoclonal antibody called bertilimumab, which is a highly specific inhibitor of eotaxin-1, a protein that plays an important role in the inflammatory cascade. These quality issues really took the wind out of the company's sails, but now it's back. It has solved the problems and is in Phase 2 for an orphan disease called bullous pemphigoid, a blistering skin disease, and for ulcerative colitis, an inflammatory bowel disease. This company could be worth magnitudes over what the market is valuing the stock at now.
TLSR: Again, we're talking about a company in the low micro-cap range. How does this stock get recognized and bid up when it's so small?
JN: It's not just money managers that bid up the price. The big drug companies are also a powerful force in the small-cap arena. I think Immune Pharmaceuticals will be squarely on the radar of the big pharmas, which are looking at these indications. Orphan diseases are very attractive, and ulcerative colitis is an enormous market. Just look at Celgene Corp.'s (CELG:NASDAQ) acquisition of Receptos Inc. (RCPT:NASDAQ) for $7.2B, net of cash. Even though Celgene already has a PDE4 inhibitor, Ortezla (apremilast), for a series of autoimmune diseases, including ulcerative colitis, Receptos has ozanimod, which is in Phase 3 for multiple sclerosis and Phase 2 for ulcerative colitis, and has a Crohn's disease trial in the plans.
TLSR: I think you have a couple of other names you wanted to mention briefly. Would you go ahead with those?
JN: Similar to some of the names we've already discussed, Rexahn Pharmaceuticals Inc. (RNN:NYSE.MKT) is developing targeted anticancer therapeutics based on biomarkers of disease, with the goal of improved efficacy and better tolerability than traditional chemotherapeutic agents.
The first drug is called Supinoxin, a highly specific oral anticancer drug that targets phosphorylated P68, which is uniquely overexpressed on a variety of solid tumors. By targeting phosphorylated P68, Supinoxin blocks a cascade that leads to cancer cell proliferation. The company has preclinical data that looks very encouraging, and now it is in a Phase 1 dose-finding study, with a goal to move into a Phase 1/2 trial for triple-negative breast cancer, a very difficult disease to treat, in 2016.
"If a biotech company you own raises cash, as long as it is putting that cash to effective use, you should be OK with that."
The next drug is RX3117, an oral nucleosite compound currently in Phase 1b. The drug selectively targets and kills cancer cells. Preclinical data shows potential utility in a number of solid tumor models, and that data looks very interesting, specifically in patients who are resistant to a commonly used cancer drug called gemcitabine.
The final drug is Archexin, currently in Phase 2a in patients with metastatic renal cell carcinoma. The drug has a validated mechanism of action known as Akt-1, and management at Rexahn thinks the drug has, potentially, the best-in-class approach. Archexin has completed a Phase 1 study and showed good tumor response, with median survival superior to standard of care, and we should see more data from the ongoing study in 2016. Rexahn has lots going on with three very interesting, early-stage anticancer drugs, and a sound and potentially rewarding development program.
Biota Pharmaceuticals Inc. (BOTA:NASDAQ) is an interesting antiviral company with multiple clinical programs and pharmaceutical partners. The company has too many products to effectively talk about here, so I'll just highlight what I see as the biggest potential opportunities for the company.
The lead drug is vapendavir, a potent capsid inhibitor that shows good activity against rhinovirus. The market opportunity is to target high-risk patients with asthma or COPD that become infected with the rhinovirus. It's a potentially huge market, and the company is currently in a Phase 2 study, with data coming in the second half of 2016.
The next drug is BTA585, which is a respiratory syncytial virus (RSV) fusion inhibitor. The target market looks somewhat like a barbell, because RSV is very common in infants and toddlers, then tends to get under control, then comes back and is common in the elderly. It's a huge market—potentially up to 10M patients a year in the U.S., and the preclinical data shows a dose-dependent decrease in viral load in animal models. The company is in Phase 1 studies, with top-line data expected early in 2016, so that should act as a nice catalyst for the shares.
Biota also gets royalties on two influenza drugs, Relenza (zanamivir) from Glaxo and Inavir (laninamivir octanoate) from Daiichi Sankyo Co. (DSKYL:OTCPK) in Japan. The company is well-funded and has lots of clinical catalysts coming in 2016, so this is one investors should definitely watch.
Jason Napodano of BioNap Consulting formerly worked for Zacks Investment Research as the company's senior biotechnology analyst. Prior to his tenure at Zacks, Napodano spent three years on the buyside with Eastover Capital in Charlotte, N.C., where he focused on large-cap equities and specialized in healthcare, energy and technology. Prior to joining Eastover, Napodano worked as a research scientist for TechLab Inc., a biotechnology company focused on developing diagnostic kits and vaccines for infectious diseases. He also spent a year working in a lab at the Fralin Biotechnology Center, and a year working for a cancer researcher in Virginia. Napodano has a bachelor's degree in biochemistry from Virginia Tech and a master's degree in business administration and finance, with a concentration in securities analysis, from Wake Forest University. Napodano is also a Chartered Financial Analyst (CFA).
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1) Dr. George S. Mack conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report and The Life Sciences Report, and provides services to Streetwise Reports as an independent contractor. He owns, or his family owns, shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of Streetwise Reports: Can-Fite BioPharma Ltd., Rexahn Pharmaceuticals Inc., Biota Pharmaceuticals Inc., BriaCell Therapeutics Corp. The companies mentioned in this interview were not involved in any aspect of the interview preparation or post-interview editing so the expert could speak independently about the sector. Streetwise Reports does not accept stock in exchange for its services.
3) Jason Napodano: I own, or my family owns, shares of the following companies mentioned in this interview: None. I personally am, or my family is, paid by the following companies mentioned in this interview: None. My company has a financial relationship with the following companies mentioned in this interview: Can-Fite BioPharma Ltd., RedHill Biopharma, Actinium Pharmaceuticals Inc., BriaCell Therapeutics Corp., Immune Pharmaceuticals Inc. I was not paid by Streetwise Reports for participating in this interview. Comments and opinions expressed are my own comments and opinions. I determined and had final say over which companies would be included in the interview based on my research, understanding of the sector and interview theme. I had the opportunity to review the interview for accuracy as of the date of the interview and am responsible for the content of the interview.
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