A few thoughts: It is becoming clear that 28 d
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Posted On: 02/25/2021 11:14:22 AM
A few thoughts:
It is becoming clear that 28 day endpoint analysis may be too short. Many trials (and I think that includes us) are not meeting their primary endpoints with S/C patients as patients on placebo are being kept alive beyond 28 days using vents and steroids (SOC). Hence I believe we barely missed primary, The FDA is extending our analysis to 42 or 60 days where we have or will make Stat Sig and get an EUA or possibly a full approval as we have completed Phase III trial. This is why NP is not talking right now. They have to look at all the data at these longer timelines and reassess P-Factor. They likely know the outcome is good and we are now also talking about who the FDA “suggests” we should partner up with considering those partner’s medicines. The discussions also have consequences for our applications with both COVID and HIV in both Canada and the U.K.
We could be looking at an announcement that includes:
- A temporary EUA while further analysis is done for full Approval
- EUA approval in the US, UK and Canada simultaneously
- NASDAQ uplisting
- And acceptance of our submission for an HIV BLA in the UK and Canada.
The continual mutations and increasing severity and infectiousness of new strains of COVID has forced the FDA to change tack and finally realize the exceptional capability of LERON for all mutations with its MOA, ease of administration without manpower and time, and safety of combo use with other treatments in combating the virus.
This is why I am not selling right now. The importance of such an announcement would be highly significant and would require a coordinated release by the government in the public domain.
It is becoming clear that 28 day endpoint analysis may be too short. Many trials (and I think that includes us) are not meeting their primary endpoints with S/C patients as patients on placebo are being kept alive beyond 28 days using vents and steroids (SOC). Hence I believe we barely missed primary, The FDA is extending our analysis to 42 or 60 days where we have or will make Stat Sig and get an EUA or possibly a full approval as we have completed Phase III trial. This is why NP is not talking right now. They have to look at all the data at these longer timelines and reassess P-Factor. They likely know the outcome is good and we are now also talking about who the FDA “suggests” we should partner up with considering those partner’s medicines. The discussions also have consequences for our applications with both COVID and HIV in both Canada and the U.K.
We could be looking at an announcement that includes:
- A temporary EUA while further analysis is done for full Approval
- EUA approval in the US, UK and Canada simultaneously
- NASDAQ uplisting
- And acceptance of our submission for an HIV BLA in the UK and Canada.
The continual mutations and increasing severity and infectiousness of new strains of COVID has forced the FDA to change tack and finally realize the exceptional capability of LERON for all mutations with its MOA, ease of administration without manpower and time, and safety of combo use with other treatments in combating the virus.
This is why I am not selling right now. The importance of such an announcement would be highly significant and would require a coordinated release by the government in the public domain.
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