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Re: falconer66a post# 345698

Thursday, 01/20/2022 12:02:34 PM

Thursday, January 20, 2022 12:02:34 PM

Post# of 463609
falconer66a

Thanks for your comment. In trying to answer the question Investor posed, whether high participation in roll over trials leads to a higher likelyhood of drug approval, it is quite logical to assume that the participants may have learned something about the drugs success during the earlier trial, and, if so, that their high participation in the follow up study might be correlated with a higher chance of drug approval.

While I argue that such high participation must necessarily help the sponsor gain valuable information that logically should facilate a more successful case to the regulatory authorities for approvals, I have trouble seeing how patient decisions to continue is also INDEPENDENTLY OF HELP THIS GIVES THE SPONSOR, is further correlated with increased chance of success since patients logically should continue any drug that is reasonably safe in cases where there are no other drug alternaties.

I suppose that the more the trial continues with participants, the more likely it leads to an eventual approval, and that they are willing to go on en-mass does provide an advantage that pans out.

But, what can it prove if the patient (or his advisors) think the drug is working? or just thinks it is advisable to continue, working or not.

Unfortunately all this is speculation based on my logic, since I could not locate any data to answer the question. Also, Doc's comment throws into doubt how many actually did roll over, which introduces another issue. But, if we had a very high roll over 100% except for drop outs, I don't thank that materially changes the question or the answer.
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