Thursday, December 18, 2014 7:55:25 PM
EbolaCide is almost a zero risk proposition for NNVC. It’s got upside, and extremely limited downside: the opportunity cost is limited to the single digit number of weeks that working on it did anything to delay FluCide or MersCide coming to market. You could make an argument about revenue-foregone in the area under the curve, but that’s about it. You could also query whether critical corporate resources are being expended on EbolaCide which will prevent FluCide continuing. If the answer is “no,” it’s hard to see how this is high risk.
The reasons why EbolaCide is so low risk include:
1. The company is buffered by its pipeline. For any pharma (so this is the case with NNVC) with multiple drugs NEAR THE FRONT OF THE PIPELINE, and the RESOURCES TO BRING THOSE DRUGS THROUGH TESTING, if there were complete and total failure of any single drug it would not be a death knell. Disappointing, yes. Impact short term stock price, yes. Corporate doom, no. Bring out the next drug.
If you were to bet which of the two drugs - FluCide or EbolaCide - would most likely succeed, FluCide is the logical choice. FluCide is the drug that was worked on most carefully, and it's the one that is officially proceeding through formal tox. EbolaCide was brought out of mothballs in response to the crisis. It’s a rush job. Although knowledge about Ebola has grown in the last few years, the virus is complex and the general data on it is significantly less than for influenzas. Because of the lethality of Ebola, NNVC cannot do the robust exploration and testing that they were no doubt able to do with flu viruses. Frankly, one would expect a better showing coming out of FluCide than out of Ebolacide II.
The highest risk factor is always Unknown Unknowns (called “unk unks” in aerospace). This is not like solving for X. An Unknown Unknown is something you don’t even know exists – it’s Q. It was an Unknown Unknown that led to impaired performance of the original EbolaCide compound. Could there be another Unknown Unknown that impacts Ebola II? Sure. Then it’s back to the lab to engineer another variant. It is only logical to expect a better showing coming out of FluCide than out of Ebolacide II. NNVC is going to do a lot of learning with Ebolacide II. If Ebolacide II is 99% effective, it’s possible that it won’t be reworked. But given what they will learn, an Ebolacide III would be even better.
2. Efficacy compared to competition. What is the alternative to EbolaCide? (Let's say we're playing by formal FDA rules, instead of being in an emergency situation in Africa.) If EbolaCide can show a statistical improvement over the established Ebola treatment, e.g., 1%, then FDA will approve it as a drug. And what is the name of the established Ebola treatment? Right now, there is nothing.
If EbolaCide cut the death rate by half in countries where no one gets intensive supportive care, this would be a big humanitarian win for lives saved and a big win for the company. If a 50%-effective EbolaCide could be produced in big enough quantities that a whole village or neighborhood could be treated even before people were symptomatic, this would go a long way to stamping out the epidemic.
Even established vaccines like measles don’t run 100% effective. Cubicin doesn’t win every time. If EbolaCide II shows any efficacy, NNVC has a first drug to market. The cides would have shown they do no harm in humans, and provide benefit even with a version that was whipped up quickly. If EbolaCide II delivers a 30-50% survival rate, then resources allowing, it will show up in a cocktail with other treatments, just like people putting together AIDs cocktails. EbolaCide II will have to share credit with the rest of the cocktail, just like right now intensive supportive care is part of the treatment mix in the US for Ebola and all other hemorrhagic fevers. Then NNVC can go back to the lab and do even better with EbolaCide III.
Worst Case scenarios:
1. Somebody else shows up with a vaccine or effective treatment before EbolaCide gets out there. Disappointing.
2. The only potential downside would be the nightmare scenario in which even though they did animal testing, a new drug takes an 80-90% mortality rate to 100%. Odds of this happening given what we know about tox are super low.
Recent NNVC News
- NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • InvestorsHub NewsWire • 05/02/2024 02:07:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 09:53:32 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:55:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/19/2024 09:44:48 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 12/04/2023 09:08:49 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 10/13/2023 08:30:41 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 09/28/2023 08:44:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/01/2023 08:46:45 PM
- Clinical Trial of Broad-Spectrum Antiviral Drug NV-CoV-2 is Progressing Well, Says NanoViricides - NV-CoV-2 is Positioned to Fulfill Many Unmet Medical Needs • InvestorsHub NewsWire • 07/06/2023 03:16:37 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM