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manibiotech

11/14/19 2:53 PM

#251696 RE: Dan88 #251694

Excellent post
Mostly agree what you said
Only confusion is the halt . Logic will dictates that they realized PFS is messed up . Otherwise Dev stage company with no money would have done IA , applied for approval with positive PFS . But then there was that quote “ turning good news into bad “ , so I can’t reconcile both .
But overall agree with your post , well stated

sukus

11/14/19 3:08 PM

#251697 RE: Dan88 #251694

Agreed. Excellent post!

skitahoe

11/14/19 3:30 PM

#251698 RE: Dan88 #251694

A very well thought out post Dan,

In that I wasn't here when the trial halted, out of curiosity and from a standpoint of understanding the data, how long was it halted for, and when it was resumed, how long did it take to dose the last 31 patients, as I understand it, in the trial.

If the halt was for 6 months, and it took 6 months until the last patient entered the trial, it would mean that as of now, for the 300 who entered the trial prior to the halt, the last to be dosed there would now be 5 years beyond the initiation of treatment. I'm not saying these are the numbers, I'm asking what they should be, but the point I'm making is that with the exception of those who entered after the halt, most if not all are now survivors for roughly 5 years or more.

I suspect when we see the K-M, the big tail people speak about will really be impressive, and perhaps may extend out a decade or more is some of the earliest people to enter the trial are living or recently passed.

Gary

flipper44

11/14/19 3:42 PM

#251700 RE: Dan88 #251694

A couple leaps here. I don't know they are necessarily correct leaps, because not founded upon anything other than guesswork.

Nonetheless PFS is still the Primary Endpoint and OS is still the Secondary Endpoint. Although if the long tail exists and it is statistically significant, meaning there are clear separations between the some comparable groups, and FDA will have to approve the vaccine because of that, the best interest for the company is that PFS endpoint is better approved statistically significant. Besides, nobody can guarantee that the long tail will be a clear cut without unblinding.

All these have hinged on the SAP saga we have all experienced for so long.... -- Dan



Not certain the things you wrote that I highlighted in red are correct.

sentiment_stocks

11/15/19 10:52 AM

#251809 RE: Dan88 #251694

Thanks Dan... I always appreciate seeing your perspective. Excellent analysis to mull over. :)

erik007tc

12/18/19 4:54 PM

#256091 RE: Dan88 #251694

Thank you, great post

Kam8

12/18/19 8:09 PM

#256097 RE: Dan88 #251694

Nice post. Thanks