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Posted On: 08/08/2020 8:43:27 AM
Post# of 148894
Good morning folks.
We had quite a few events last week, was traveling and just catch up with them. Wanted to share some thoughts (just imo):
Results of CD10: several comments from NP and JL, safety and NEWS2 peeks would indicate we have some favorable results. The re-enforcement provided by NP, who by now should know a large parte of the analysis, by communicating the filing in UK/Europe would indicate these are very good.
The question is: do we meet the primary end-point ? or rather, can we demonstrate efficacy in several areas as measured by other parameters rather than the originally designed primary-end-point?? This is a P2 trial, that is, the end-points for P3 can be adjusted, enlarged or limited depending on what was obtained (efficacy), provided we have something to work with.
OK. Enough of this. So how does this affect us as investors?? Ideally FDA will say: "man this is soooo good", you are approved, please do a P4 as you sell the drug. This would possibly happen if we crush the p-value (in NP words) and show great secondary's.
Reading between lines imo this is not the case. We will show therapeutic benefit, no doubt about that, but will need to go to P3 (with fine-tuned endpoints) and fight for EUA in the mean time.
As investors I think we need to consider something very important: for the COVID indication time is of the essence, both for CYDY and, more importantly, for thousands of patients out there badly needing Leronlimab.
P3 will require several 100's of patients. We will take few months to enroll, gather data, analyze and get approval. There isn't time for that.
Our safer and more productive route is, then, partner with BP (COVID only).
Why???
- We do the P3 trial quickly
- We gain acceptance with FDA (this shouldn't be necessary, but, imo FDA is not playing, and has not been playing, fairly with us)
-The most important gain is to "institutionalize" Leronlimab. Once is out there being used for COVID (approved) there is no stopping of-label usage and the acceptance of the veritable therapeutic benefit in other areas (which really are the big prize).
This way COVID will be the door for HIV, NASH, PrEP, Oncology … the whole enchilada.
Apart from rewarding all of us economically now.
So, if FDA tries to continue with the same shenanigans a licensing or a partnership for COVID will be a good (and maybe the only) option.
Nader: put the data in the idem room and start making phone calls.
We had quite a few events last week, was traveling and just catch up with them. Wanted to share some thoughts (just imo):
Results of CD10: several comments from NP and JL, safety and NEWS2 peeks would indicate we have some favorable results. The re-enforcement provided by NP, who by now should know a large parte of the analysis, by communicating the filing in UK/Europe would indicate these are very good.
The question is: do we meet the primary end-point ? or rather, can we demonstrate efficacy in several areas as measured by other parameters rather than the originally designed primary-end-point?? This is a P2 trial, that is, the end-points for P3 can be adjusted, enlarged or limited depending on what was obtained (efficacy), provided we have something to work with.
OK. Enough of this. So how does this affect us as investors?? Ideally FDA will say: "man this is soooo good", you are approved, please do a P4 as you sell the drug. This would possibly happen if we crush the p-value (in NP words) and show great secondary's.
Reading between lines imo this is not the case. We will show therapeutic benefit, no doubt about that, but will need to go to P3 (with fine-tuned endpoints) and fight for EUA in the mean time.
As investors I think we need to consider something very important: for the COVID indication time is of the essence, both for CYDY and, more importantly, for thousands of patients out there badly needing Leronlimab.
P3 will require several 100's of patients. We will take few months to enroll, gather data, analyze and get approval. There isn't time for that.
Our safer and more productive route is, then, partner with BP (COVID only).
Why???
- We do the P3 trial quickly
- We gain acceptance with FDA (this shouldn't be necessary, but, imo FDA is not playing, and has not been playing, fairly with us)
-The most important gain is to "institutionalize" Leronlimab. Once is out there being used for COVID (approved) there is no stopping of-label usage and the acceptance of the veritable therapeutic benefit in other areas (which really are the big prize).
This way COVID will be the door for HIV, NASH, PrEP, Oncology … the whole enchilada.
Apart from rewarding all of us economically now.
So, if FDA tries to continue with the same shenanigans a licensing or a partnership for COVID will be a good (and maybe the only) option.
Nader: put the data in the idem room and start making phone calls.
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