Replies to post #375454 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Well said and nicely nuanced. I do not know about their plans for revealing at ASCO, or not, but your discussion of the complexity, data issues and stakeholders as well as the various other challenges is, in my book, right on the money. I think FDA is right out there with them and though the UK regulatory authority was fastest on the vaccines, FDA was 2nd. EMA was last, so I expect that could be what we see here.

I am confident that it will work out and that the FDA will stand behind its own guidance and likely led the company down this road given the contradictory constraints they put on the trial, not arbitrarily but based upon dated requirements. But the FDA can’t be arbitrary or irrational in their regulation and I do not expect that outcome.

All my personal opinion.

[DavidW2]

"they’re not appearing to be at ASCO is compelling".

Let's see what management would say in ASM. If nothing special in ASM. I don't think it will be compelling at ASCO.

[JerryCampbell]

LOL

If nwbo was presenting at ASCO, you would say that was bullish. Now they're not presenting, you think that is bullish.

Hard to go a day without a rationalization.

[skitahoe]

Thanks Diver, but in the past I believe they used ASCO to appear at the Expert's Forum, not in making peer reviewed presentations. I don't know that the virtual ASCO is lowering attendance, though it may be. My Dr. personally would rather not attend, but liked to attend the virtual presentation.

While no one can be certain of a presentation there until one is announced, if it is, I believe it will have far greater impact than in the past as it will be the unveiling of a trial that's run for over a decade for peer review, not merely the Expert's Forum, which frankly is mostly intended for investors after the fact.

I suspect that by the time of SNO and AACR/EORTC we may be doing live, or hybrid sort of conferences, but certainly hope that we'll not wait that long for initial peer review. A journal publication would surely get the job done, the question is, would it preclude a presentation at any major conference because what's being presented is known. I do believe in the advantage of hearing from those who've actually done the work, and be able to question them, something which can't be done in a Journal. I believe it possible to leave out something from the Journal presentation that could be a part of a future conference presentation.

I frankly believe that Dr. Liau and others will speak at many smaller conferences, even thought much they present will have previously been presented elsewhere. Why? Because many will want to hear from those who've done the work, and to be able to speak with them directly, and ask questions. I would hope that if an ASCO presentation is made, a virtual Q & A would follow the formal presentation. All these things should be resolved in the next few weeks.

Gary

[foxhound02]

I will not go into every point in detail, but here is the bottom line. The hardest part of writing a paper is getting the raw data together, analyzing it, and making graphs and tables. This was done by the statisticians. With the results in hand, LL could write the paper in a few days. She will be the lead author, others will submit edits and its a wrap. Also, all of the results will likely not be in a single paper. Several will ultimately be published from the study. However, the first paper will obviously focus on survival. There is no way to candy-wrap the long delay.