Question for the more knowledgable (you know who you are):
Assuming the likelihood of a successful appeal is low and another trial is needed:
a) What would the total cost and estimated total time for a P3 Alzheimer's only trial.
b) What would the cost and time for the A371, PDD and Rett trials?
c) What would be the cost and time for a preventative study trial?
d) Is there a way to have these trials run parallel (i.e., can we test the preventative group within the same larger Alzheimer's trial, or does this have to be a completely separate trial?
I have no problem waiting another ~1100 days with this group of clowns, it gives me something to look forward to reading each day but I do want to have some basic idea of what the cost will be for these trials, how much dilution will be required to fund them, if management feels that partnering to fund the trials is preferable to dilution, and most importantly, the 5th question:
e) How likely is it for the results to be replicated? Some believe it is a trial design issue, some believe that it's an ineffectiveness issue. Regardless, running an additional trial involves considerable risk that the results are not confirmatory -- so, based on what we know about ideal populations, p-values, etc. how likely is it that these results can be replicated a second time with a larger, perhaps healthier (early stage) trial group? This doesn't appear to be a SAVA situation where the data was fabricated and therefore not replicable.
Buckle up, longs. I've been in this position several times, It's not fun. But it's like a boxer losing a consecutive round. The fight is far from over. It'll be interesting to see what happens to Dr. M but I believe that he will stick around, for better or worse. I also believe he will design a proper P3 trial for A371 and a proper P3 trial for Alzheimer's, but that will not be enough to silence the wolves. I expect this board to be a forest full of howls for the next 36 months.
Thanks.
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