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Dr Bala

09/09/22 8:47 PM

#512495 RE: exwannabe #512490

Yawn. The data is out and it looks great.
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flipper44

09/09/22 8:50 PM

#512498 RE: exwannabe #512490

Surely you’ve considered that had they resumed enrollment, they’d have to place 17 in placebo and zero in treatment. Maybe we just wait to find out more upon further data release.
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sentiment_stocks

09/09/22 10:15 PM

#512516 RE: exwannabe #512490

You specifically said that the FDA never allowed the trial to resume screening, and even now (in your post), you state that the first action the FDA took was to "issue the partial hold that blocked screening new patients."

Then of course, in February 2017, the company announced that the FDA had lifted the halt that halted the screening of new patients.

It is YOUR THEORY (and not a hard fact) that the FDA did not let them screen new patients, despite the HARD FACT that the FDA lifted the halt allowing them to screen new patients.

You have no HARD PROOF that your theory is a fact... you just offer your statement that it is a "hard fact."

You may think that your THEORY is the only logical conclusion to come to, but it really does have an obvious flaw.

It simply doesn’t make sense that the FDA would lift the halt to screen new patients, and then not let the trial (should they have chosen to do so) screen new patients.

You know, we've had this same conversation countless times over the years, so your theory is not new to me (and others that have been here for some time), and my response is likely not new to you either.
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biosectinvestor

09/09/22 10:19 PM

#512517 RE: exwannabe #512490

They have approximately the anticipated number of treatment arm patients, as I recall, just not the placebo patients, which I have explained, suggests that enrolling more placebo patients and delaying their care when there is no placebo arm because of the crossover and also given the issues around PFS, would be unethical. Any difference you might suggest would likely be the result of other factors, but I think your take is flatly incorrect.