blafarm, I agree, as a matter of fact, I wrote
Post# of 155150
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Posted On: 06/17/2020 9:37:25 AM
blafarm,
I agree, as a matter of fact, I wrote a long mail to NP (after a suggestion from the board) pointing out the fact that cutting the enrollment before we had 75 patients was very detrimental to the power of the trial, more so accounting for the fact that this is a P2 and we need approval in base of the results.
Thankfully the enrollment picked up and he decided to extend this until today, but, as you well point out, the more patients the better the power and the more convincing our results will be.
If we are recruiting at, say, one patient per day a couple of weeks more would be a well-spent delay. However, I believe they are planning a double-whammy with the FDA, M2M and S2C results one after the other so the M2M results are reinforced by the S2C leaving FDA little wiggle room for not approving both.
Also, a double-whammy will be VERY beneficial for the SP.
I think NP knows something we don't know (maybe he has had coffee with Dr. Patterson
) and I defer to his judgment.
I agree, as a matter of fact, I wrote a long mail to NP (after a suggestion from the board) pointing out the fact that cutting the enrollment before we had 75 patients was very detrimental to the power of the trial, more so accounting for the fact that this is a P2 and we need approval in base of the results.
Thankfully the enrollment picked up and he decided to extend this until today, but, as you well point out, the more patients the better the power and the more convincing our results will be.
If we are recruiting at, say, one patient per day a couple of weeks more would be a well-spent delay. However, I believe they are planning a double-whammy with the FDA, M2M and S2C results one after the other so the M2M results are reinforced by the S2C leaving FDA little wiggle room for not approving both.
Also, a double-whammy will be VERY beneficial for the SP.
I think NP knows something we don't know (maybe he has had coffee with Dr. Patterson
) and I defer to his judgment.
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