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kfa670

05/07/24 2:30 PM

#689479 RE: CaptainObvious #689476

Ive been wondering this as well

RobotDroid

05/07/24 2:32 PM

#689481 RE: CaptainObvious #689476

The silence from missing management, the lack of pr's, the lack of submission/acceptance data and time frames, the ineptness of mismanagement. I think that about covers it.

Nemesis18

05/07/24 2:33 PM

#689482 RE: CaptainObvious #689476

6. Unforeseen Regulatory Issues ?

Nemesis18

05/07/24 2:37 PM

#689485 RE: CaptainObvious #689476

6. Unforeseen Regulatory Issues ?

antihama

05/07/24 6:08 PM

#689556 RE: CaptainObvious #689476

Ahh, the $64,000 question. I guess it's a combo of 1 and 5. And when you say them, you don't want to upstage or put pressure on the MHRA.
What, I need to get the right answer to get the $64,000? Oh well.

manibiotech

05/07/24 6:15 PM

#689559 RE: CaptainObvious #689476

You can look at the history of publication of interim blinded data and final data . It took months and months . And in case of interim unblinded data , they weren’t able to get it published in tier 1 or 2 journals . So taking time is not surprising I think .

XMaster2023

05/07/24 11:52 PM

#689592 RE: CaptainObvious #689476

5 Approval.
Best advertisement in town!

Nemesis18

05/08/24 7:18 AM

#689596 RE: CaptainObvious #689476

5. And when you say them, you don't want to upstage or put pressure on the MHRA.



I certainly feel that it is the case that the MHRA are under enough pressure, as it is, with this DCVax-L MAA application, and establishing it efficacy !

Which, of course, is the role of an independent, unbiased Regulator.

If the MAA is granted, rest assured, it has undergone microscopic scrutiny, and then NWBO will certainly have something to crow about !

exwannabe

05/08/24 7:58 AM

#689600 RE: CaptainObvious #689476

2/3 UCLA

The only responsible parties are UCLA and Nature (plus their reviewers). NWBO is not involved, so skip choice 1, I find it kind of unlikely that the Nature side would be much of a holdup. So that leaves UCLA.

very reasonable that a review cycle could take some time, especially if authors are busy. This is an interim update on an ongoing P2, not exactly earth shaking news (despite what longs here think). I see no reason why all authors would drop what they are doing to respond to a review request code blue.

I also see no reason to sync with some external event. Sometimes papers are timed in conjunction with a conference presentation to avoid pre-disclosure. But with the pre-print already disclosed that looks unlikely (though I guess a possibility).

I previously thought it possible that UCLA would skip this if the final data was soon. But with the trial still ongoing, and looking like they might be still trying to reopen enrollment, the paper on the primary analysis could be years away.

biosectinvestor

05/08/24 8:21 AM

#689602 RE: CaptainObvious #689476


Nature can take a really long time even with breakthrough papers. I have seen it before. Also, NWBOhas nothing to do with the article, it is UCLA and Nature.