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I regard those results as spectacular on a

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Fosco1 Member Level  Wednesday, 11/11/20 08:59:23 AM
Re: timberwolf7 post# 2503
Post # of 2552 
I regard those results as spectacular on a small population

Now, goal of a phase III is to replicate in larger population what is seen in a phase II, large enough to become mathematically and statistically significant (eg with p<0.05)

Is this goal achieved ? It does not seem to be at the 75% interim otherwise they would have stopped for early benefit, it does not seem it will be at 100% as well. The reason is not the compound, the reason is the design of the Ph III : it needs to be redesigned either by changing the SAP (for instance allowing historical control) and this will require talks with the FDA (lengthy : again with such results my assumption should be that the FDA should say YES product is good and historical control is enough) or by doing a new phase III trial. I am guessing they are waiting to see if this trial can finish till completion (results of conditional power analysis) prior talking to the FDA as they might suspect this talk will be longer than completing the trial as designed initially.
Reading between the lines as this company does not seem to be willing to communicate things as they are.
I am sorry, but that's my view right now.
NB : I hope I will be proven wrong by end of year, in the meantime I sold my shares and wait for this next PhIII news
Fosco

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