Replies to post #401749 on NorthWest Biotherapeutics Inc (NWBO)

[Basin Street Blues]

Even easier than that, DI is saying ,

We met primary and secondary and failed the rest ..and due to this the peer revue has meant a new level of complexity explaining it ..

And yep $5 I'm out ...

JMHO

[Dr Bala]

Great summary of the points. Agree with your conclusion regarding the approval. LP said last year that her objective is for this therapy to become the new SOC.

[flipper44]

JMHO
Based On FeMike’s recent post of his conversation with DI.

[exwannabe]

# 4 and # 5 are probably very encouraging, except that it also means absolutely nothing about even the vaguest idea regarding estimated TLD and publication timeline. TLD announcement does not appear to be their number one, two and three priority, but trying to obtain approval does.

Why is it every other dev stage bio will announce their plans for BLA/NDA submission and NWBO can not?

Do they not have a timeline for submission now that it has been 11 months since datalock? Most companies would be nearing the PDUFA date by then.

[EMHLondonUK]

On Pt 2 to confirm, England is not operating under any meaningful Covid restrictions at this point. I’m sure MHRA is dealing with a number of “yellow card” reports about vaccine reactions and is involved (on the periphery) on if/when injections will be extended to 12-15 year olds (approved yesterday) and over 50s mRNA boosters (still being debated).

Civil servants in Whitehall are attending office “in person” at about 25 percent, but the entire nation has settled into a hybrid WFH/into office model pretty comfortably now. Assuming inspections happen before any big further surge into the winter, they should be able to visit without material restrictions.

[learningcurve2020]

That's speak for no journal submission at all.

1. Can’t say if journal articles submitted or not.

Deflection on Sawston. The real question remains unasked and unanswered; What piece of the pie do retail own / receive?

Covid comment relayed is material to investment decision making.

2. Can’t say if Sawston inspection conducted yet or not, but can say Covid no longer seems to be an impediment to that process’s timeline.

So no journal publication means no TLD. I see.

The prestigious Dr Liau and UCLA could not explain it sufficiently so better to wait a year or two.

By now hundreds of people are in possession of TLD unless, of course, the data is still with the statisticians.

3. Can say that it appears they want TLD and Journal publication close together because they anticipate needing to clearly explain primary endpoints, because they are a recent innovation used by the FDA. This is essentially what Senti just said today or yesterday.

Another material leak on financing. The company states in the 10q they are a Going concern. The company allegedly /actually threw out a share price figure during said Quiet period. Can't make it up.

Reverse Split to $5 = "Easier".

4. Aren’t worried about needing financing anytime soon, but would be easier to finance at 5.00. (Note: I’d be totally fine with that, I bet I could almost speak for everyone on that, as long as it’s not obtained by a prerelease reverse split.)

More material leaks as it now somehow appears TLD is unrelated to Approval time line. Perhaps thousands are now in the know??

5, Last but not least, this is not about getting TLD out fast, according to DI, it is about trying to obtain approval, and a later public TLD announcement won’t slow down approval decision being made.

Material leaks...Quiet period breach...Nobody seems to care. Just give us something to talk about.

[BWIS]

4. Aren’t worried about needing financing anytime soon, but would be easier to finance at 5.00. (Note: I’d be totally fine with that, I bet I could almost speak for everyone on that, as long as it’s not obtained by a prerelease reverse split.)

First (qualifier) I hate that I'm saying this but:

If DI mentioned $5 specifically that could be a "tea leaf" for up listing.

[anders2211]

1. Can’t say if journal articles submitted or no

do you or anyone know if before submitting an article if it's normal to haveing it first peer reviewed?

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.

Is this peer-reviewing after or before a journal has agreed of publishing thats the question if we will see publication this year