On EUA, Frank on YMB (10+years experience in EMA r
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Posted On: 08/15/2020 11:20:27 AM
On EUA, Frank on YMB (10+years experience in EMA regulatory) wrote:
Two FDA information and why I believe that these results to Emergency approval:
1) the following FDA link (Provided already yesterday here) makes it clear: Phase II trials are considered „late stage“ trials and „late stage trial“ is basically a prerequisite for EUA. We have that with M/M (and soon also with S/C phase IIb/III)
https://www.fda.gov/drugs/coronavirus-covid-1...#dashboard
2) See the following information on the key consideration of FDA for granting or not granting EUA. I copy- paste from the first point of the following FDA - file:
https://www.fda.gov/media/137574/download
„FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks.“
That most crucial point is pretty clear. There is absolutely zero safety signal in the M&M Phase 2 trial (but the opposite: less adverse events than in placebo!) Zero safety issue in the phase 3 HIV Trial. Zero concern in the interim report from the DSM committee on the CYDY S/C phase 2b/3 Trial.
In the M/M trial we also have the statistically significant result for NEWS2 with a p-value of 0.023. that means that this observed difference in NEWS is with a 97.7 % chance due to the effect by leronlimab (and not a by chance finding). Plus the clearly better total clinical score where 30% did not improve in the placebo group on the primary endpoint, but only 10 % in the leronlimab group: that is a 2/3 (66%) reduction. That did not met stat sign, but it is a strong clinical difference which clearly supports the credibility of the NEWS2 result with a remarkable low p-value of 0.023.
If you ask me - it does not only qualify for EUA (point 1 above), but must approval for EUA is the logical result. Still I do not expect it for Monday or Tuesday, because I would expect that FDA still may have few questions on details, maybe references or require to study the safety data from the HIV trial or questions on the availability of leronlimab. There may be several questions which might be posed by FDA and responded by CYDY during these days (that goes by email) and is very normal procedure. Let‘s see, obviously I cannot guarantee, but having studied now several FDA links on Covid including FDA“s considerations on Remdesivir, the most reasonable outcome is EUA in the very near future.
Not much more can be done at this stage. Nobody knows the future, we can only try to estimate it on the basis of the available information. Considering the above, I will continue to add shares early next week until we get EUA. The waiting is painful, but no pain, no gain. Tell me any new great discovery where people said: hurrah, here it is what will change our life to the better...? Rather the opposite is true: you have to overcome first much resistance. And is going to happen: with our good data“
Two FDA information and why I believe that these results to Emergency approval:
1) the following FDA link (Provided already yesterday here) makes it clear: Phase II trials are considered „late stage“ trials and „late stage trial“ is basically a prerequisite for EUA. We have that with M/M (and soon also with S/C phase IIb/III)
https://www.fda.gov/drugs/coronavirus-covid-1...#dashboard
2) See the following information on the key consideration of FDA for granting or not granting EUA. I copy- paste from the first point of the following FDA - file:
https://www.fda.gov/media/137574/download
„FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks.“
That most crucial point is pretty clear. There is absolutely zero safety signal in the M&M Phase 2 trial (but the opposite: less adverse events than in placebo!) Zero safety issue in the phase 3 HIV Trial. Zero concern in the interim report from the DSM committee on the CYDY S/C phase 2b/3 Trial.
In the M/M trial we also have the statistically significant result for NEWS2 with a p-value of 0.023. that means that this observed difference in NEWS is with a 97.7 % chance due to the effect by leronlimab (and not a by chance finding). Plus the clearly better total clinical score where 30% did not improve in the placebo group on the primary endpoint, but only 10 % in the leronlimab group: that is a 2/3 (66%) reduction. That did not met stat sign, but it is a strong clinical difference which clearly supports the credibility of the NEWS2 result with a remarkable low p-value of 0.023.
If you ask me - it does not only qualify for EUA (point 1 above), but must approval for EUA is the logical result. Still I do not expect it for Monday or Tuesday, because I would expect that FDA still may have few questions on details, maybe references or require to study the safety data from the HIV trial or questions on the availability of leronlimab. There may be several questions which might be posed by FDA and responded by CYDY during these days (that goes by email) and is very normal procedure. Let‘s see, obviously I cannot guarantee, but having studied now several FDA links on Covid including FDA“s considerations on Remdesivir, the most reasonable outcome is EUA in the very near future.
Not much more can be done at this stage. Nobody knows the future, we can only try to estimate it on the basis of the available information. Considering the above, I will continue to add shares early next week until we get EUA. The waiting is painful, but no pain, no gain. Tell me any new great discovery where people said: hurrah, here it is what will change our life to the better...? Rather the opposite is true: you have to overcome first much resistance. And is going to happen: with our good data“
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