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flipper44

05/25/22 1:28 PM

#478454 RE: exwannabe #478438

First, admit you know five censors came from the difference between the number at risk versus the number surviving at five years, and no censors are evident at one, two, three or four years.

Next, admit you know why they wouldn’t have been able to end the trial at the time of an en masse crossover for ethical reasons, and that not ending the trial (even if they thought they had persuasive numbers), could have been due to the inability in 2015 to convincingly demonstrate (for approval reasons back then (older technology)) PFS versus psPD and because the FDA back then, held the position in writing (later to be changed) PFS was not a sufficient endpoint for approval (See IMUC).

In fact, you believed PFS wasn’t enough back then.

(Besides, they didn’t have automated closed system manufacturing technology back then)

flipper44

05/25/22 6:04 PM

#478572 RE: exwannabe #478438

Ex, I Forgot to address this point of yours.

Then why was the trial still a year from 224 PFS events?



You don’t know when 224 PFS events were reached, right?

You do know when the combined number of 248 pfs events with 231 OS events was reached.

You can guess 248 pfs events were reached in October 2016, but that number is 24 more than your number above. So you unknowingly answered your own question.

Note: About 20% of original treatment PFS data points are still censored.

Note: Next up, confirmed PFS.

MI Dendream

05/25/22 6:29 PM

#478578 RE: exwannabe #478438

As I recall the KM graph without looking at it, there were 7 LTFU censors based on there placement on the graph, and 5 - 6 that had not yet reached 3 years. One mark was difficult to discern if it represented 1 or 2 patients. This makes absolute sense because the data was shown in mid-Novemeber so it had to be compiled at least one month earlier and we know the final enrolled patients were enrolled in November 2015.