Replies to post #401735 on NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Thanks FeMike. That was very interesting :-)

[Dr Bala]

Thanks for the info.

[anders2211]

Femike,

Thank you for sharing its super helpful.

- They are still in peer-reviewing didnt expect that. Did you get the impression the peer-reviewing is almost done and over or still needs much more time?


Thanks

[VikingInvest]

Thanks for sharing.

As I mentioned last week, and what you just confirmed, is that Sawston Cert and TLD PR's are NOT interdependent. Anders et al, were frying me over the fire for stating that.

[Pharmboy46]

Thank you for sharing your conversation

[biosectinvestor]

Thanks for the update on the conversations and your personal evaluation of it. It is interesting color.

[exwannabe]

- He made reference to CVM rushing to release TLD without a supporting paper and getting beaten down even though they have some data and results that are actually, potentially, positive; said now they are stuck in a quiet period until scientific publication just like NWBO, but their quiet period is marred by a muddy TLD release. He stressed that the goal is approval, not getting TLD to market, and that rushing to release TLD does not get them to approval any faster. I know what you’re thinking and no, I did not take this as DI equivocating muddy CVM data to muddy NWBO data. I think it has more to do with how they are analyzing the data, which leads me to:

Way to go DI!

Problem is, CVM clearly missed the trial primary endpoint and the subgroup analysis they are hyping is what is called exploratory. And a pointless one at that as you can not identify low risk patients (the population it worked in) at the time you must treat them. And still no true TLD (the comparison between the 2 main trial arms).

Both companies have taken over a 50% hit from the highs when TLD was expected. CVM for hyping a failure, NWBO for raising crickets.

[HappyLibrarian]

Thank you for having the conversation. It is about what I expected to hear and was presented in a balanced way.

[marzan]

Thanks for sharing FeMike. Glad you are now relaxed/stress free to some extent. You used to be kind of restless; glad you feel better now. The conversation sure sounds like The Trial Did Not Fail. That is reassuring and is very important for me.

[Mionaer1]

Thanks FeMike. Very interesting and helpful.

[marzan]

Looks like inspection is done and are waiting on the response from MHRA; could be any day. You started out saying you talked to DI recently. Today is Monday. Did you talk to him last week?

[ison929]

Thank you so kindly for sharing.

[CrashOverride]

Dave Innes is very approachable. I don't know why people get so upset with NWBO regarding transparency. Tweeting at Elon Musk didn't help CVM get approval. Though it did help Geert dilute shareholders before their shareprice took a nosedive.

[tucsonchas]

Thank you FeMike for making the call to DI and reporting back to the board. Much appreciated.

[ATLnsider]

FeMike, thanks for sharing

[Recondo74]

Thank you for taking the time for an excellent summary, FeMike.

[anders2211]

- He mentioned that they can’t just call these scientists and doctors and ask them to rush or give updates/timelines because their investors would like to know. This makes me think the authoring of the paper is complete and it is in review/approval stages. Now I’m not terribly familiar with medical journal publication processes, so I’m not sure if this would imply these revisions/iterations are being done pre or post submittal.

so NWBO taking its time to get peer-reviewing done, not rushing these "scientists and doctors" to get the updates and timelines. According to DI these scientists and doctors do not need to be rushed for the investors that would like to know... How about patients would they not like to know?

According to Vubru

Someone will always be slow to take care of these requirements, and with 60+ co-authors, I can see this taking up to a couple of weeks between submission and actually being sent out for review. So my guess is that they by today would have gotten to the point of having an article submitted. As I have said in prior posts, if their original planned PFS and OS outcomes (DCVAX vs. the internal placebo group) are not significant and the only significant findings are the comparisons to historical controls, getting this accepted by NEJM or Lancet may be challenging. However, I assume they would want to try one or both of these top journals first. These high end journals do an internal editorial board review of submissions before the paper is sent out for peer-review.

If they are now in peer-reviewing then normally it would take a couple of weeks but the phase they are in I would say 2 months out still for the scientific publication.

[Hopeforthefuture3]

FeMike, much thanks. To me sounds as if the draft of the paper is done but being reviewed by many authors - perhaps before submitting to the journal(s) for their review. If this is the case then we are in another one of those multi-month processes and imo we wait until 2022 to get paper and tld. Alternatively perhaps it is back from a journal and trying to get authors to agree with comments/ changes - then still might see data in 2021. Who knows...