Ann: Third complete response in PTX-200 AML Trial, page-195

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28/11/19

00:34

Post #: 41673486
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Originally posted by supertramp: ↑

Gosh Southoz, I know some see the glass as half full but your post is very pessimistic.

"So the study has been halted. Presumably by the DSMB because of the three cases with adverse side effects.

Hence the trial was very likely to fail on the primary outcome – which was safety."

Unlikely to fail on safety imho. Only one person was dose limited.

"If the amendment gets through the FDA / Ethics the trial re-starts early next year. If the amendment is not approved the trial is abandoned."

Unlikely to not go through, as it relates to safety.

"If the new schedule doesn’t fix the problem (adverse effects continue) then presumably this will also cause the trial to be abandoned or to fail on its primary safety outcome and so not trip over to P2."

But it probably will fix the problem. In fact "problem" is probably too strong a word. Observations have been make, and adjustment planned. This is pretty normal with dosing and trials with multiple agents/actions.

But even if your worse fears come true, it's worth remembering that it's the breast cancer trial and ptx100 where one should put their excitement imho.

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i think people read it as success of 3/15 patients so a tiny success rate but missed “total eradication of cancer” in three human beings

PTX Price at posting: 10.0¢ Sentiment: Buy Disclosure: Held
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Ann: Third complete response in PTX-200 AML Trial, page-195

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