Replies to post #514751 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

This is inconsequential in my dd. We all knew the change was made. We can guess why it was made when it was made but ultimately it is just a guess. Some wildly speculate about the reasons and this speculation always seems to put nwbo in a bad light for some reason. I believe NWBO has been very deliberate with all their actions surrounding RA authorities and I believe the timing of the clinicaltrials.gov update was done for a reason. But in the end, this minor detail is inconsequential.

Have a good one Flip.

[WojD40]

I agree it was a BS excuse, but I think there was a glimpse of what they're actually up to in the refusal to update the US endpoints.

I remember there was an air of resentment when David was later discussing the EU change. I sensed genuine surprise and irritation that the Europeans 'leaked it'. The resulting run up in price was unexpected and unwelcome by the company because they had decided by that point (September 2020) to go quiet until they were further along in manufacturing and regulatory matters.

Here is my speculation about those months.

With all sincerity, they announce data lock in August and promise TLD in September.

Some unknown catalyst causes them to decide on the strategy we are still living with today. They seemed to have turned on a dime, so I think this is an outside party introducing some new element. No way the SAB and BOD just change their minds at the very last moment, especially after the COVID delay. This came from outside and at the eleventh hour.

They prepare for some egg-on-face and write the infamous Oct 5th U-turn PR announcing the quiet period and Journal route. But wait...in the meantime, quite unexpectedly, the EU updates the endpoints and creates demand for the stock that sails it to $2.50.

With me so far...?

It might be that they already had a handshake, first refusal, favoured nations deal in place with a buyer, and in that would've been a gentleman's agreement that the company not do anything to hype itself and inflate the share price. Changing the endpoints on the FDA site would've added fuel to the fire, and I believe they needed to be left alone at that point. Hence the slightly panicked resentment I detected in their tone almost two years ago. The run up in price was a risk to the deal. That's why the company didn't welcome it, and that's why they've been downright obstinate in updating the FDA (despite begging them to do so by some on this board). This is too wilful an act to be mean nothing. They've had to repeatedly justify their lack of action and still chose not to amend the 'error'. So that means it wasn't an error.

The cat was out of the bag on May 10th, so that's when the US was updated (when it would no longer look like a preview event for good news, ie. hype).

Just my two dollars and fifty cents worth...

[CaptainObvious]

Besides shorts, naked or clothed, who would benefit from a low stock price? Someone who wants to purchase the company in the future, maybe. A purchase could also be in the form of a merger, or a buyout to take the company private.

[Horseb4CarT]

I’ve always guessed that not updating in the US was to keep nwbo’s moves in the dark and the adversaries guessing and/or misinterpreting until the dense sequence of announcements were disclosed.

I also got the impression that nwbo was somehow caught off guard by the NYAS PR regarding LL’s NYAS presentation. The subsequent PR from nwbo appeared rushed to me and it wasn’t released to us investors on the email list in the usual manner.

That might account for the trials database getting updated post NYAS.

Fwiw the NYAS presentation and the follow up at ASCO industry expert/booth, along with the manufacturing progress and certification status, all show that nwbo is moving forward deliberately on all necessary fronts to obtain approvals and be ready to deliver treatments at scale.

The continued passage of time after such a long trial and time since data lock and all is frustrating for all of us long time longs, however the public diligence has never been more positive overall.

We just have to wait it out a bit more and bear the negative narratives and sp manipulation in the meantime!

[biosectinvestor]

It’s absolutely NOT bizarre why they waited. 1) a key policy is still not final, and was not then (ECA); and 2) yes, the FDA approved silently, and they may have been directed that way but the FDA likes to talk out of both sides of its mouth… they will confirm that silence means approval through some low level nobody who will likely also tell you you can’t rely on anything he says.

So then you change it and then, when they get it, they have the right to pretend they never approved anything or said anything (because they do not do so as a matter of fact, and policy, as they do not at the beginning also for the first SAP, but shorts pretend this is different) about the SAP, and given Adam Fuerstein and crew, and those who use his columns to wreak havoc legally, I can imagine they were advised that since updating is on them, there were risks updating before final confirmation of actual marketing approval on the basis of the actually approval updated SAP because of the backwards way the FDA runs it’s regulatory approval process . The disconnect between the FDA approving the SAP but not themselves then confirming it with the database approval, as is done in Europe, is intentionally ambiguous and likely puts them in a risky situation if the FDA doubles back at the end of the day. I won’t explain more but I would guess that a good lawyer would advice them that there was real jeopardy if the FDA is fickle, which we all know they do sometimes. The risk might seem low, but is always a risk.

The FDA wants to be responsible for nothing financial, and will always take full advantage and opportunity to do whatever they claim they think is necessary for drug safety and public safety (ignoring their mess with opioids and other mistakes they have made that they never admit). They may at times seem to fall short of that, but that is their face saving tactic and it is very political, but that is the reality due to the LAW and interpretations of courts that for policy reasons, give the FDA that incredible discretion to be that two faced.

It sucks to be a tiny drug company and let’s face it, a complex trial like this, involving cell therapies that the FDA has been institutionally very hard on for years, was not typically what the FDA had in mind. The FDA deals with such trials consistently ultimately in my opinion, but on a very careful case-by-case basis. I believe NWBO is very carefully lining everything up, without putting the company at risk with debt, like Dendreon did. The FDA is also reforming because of things like the 21st Century Cures Act but still it is happening very slowly and even then because the organization is very, very conservative and wants to reserve all power to itself.

So yes, I can see why they delayed and why it was in fact immaterial though placing blame on the company for 5/10 that it had to do with this, when it absolutely had nothing to do with this, suits some people’s spun narrative that you can’t trust management and they are incompetent. That’s a false narrative.