Replies to post #423538 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Classic. Succinct.

[skitahoe]

Bob,

What exactly is TLD. I agree the company has all the data, but TLD is a statement from the company, normally a couple paragraphs, that summarizes the trial.

I believe this trial was exceptionally complex, it included a decision to change the primary goals, and with all that's happened in the trial, I think any attempt to describe what happened in a few paragraphs would be subject to all kinds of questions from shorts attempting to diminish what was said.

One of the big problems with putting out a TLD statement well in advance of peer reviewed data is that the company really can't answer the questions. Once peer reviewed information is presented, they can answer by citing what's been peer reviewed. Once again the company determined that a short presentation at a conference would still leave them open to questions which wouldn't be covered in that presentation. A presentation in a Journal was determined to be far more comprehensive, it will answer the greater majority of the issues the shorts could use in attempting to cast doubt.

With the decision to go with the Journal, the company also committed not to provide a TLD statement until that Journal is about to be out, perhaps they'll announce the date of the Journal when they make the TLD statement. For now, just accept what Dr. Liau and Ashkan has told everyone about people simply surviving longer than people would anticipate. If you don't like that, here's my minimalistic belief in what the TLD should say, The primary trial goal of overall survival has been met, or actually substantially exceeded. That's only one sentence, do you really need to know more than that.

Gary

[antihama]

You're right, Investors do not know, and us investors know that, but I would think they would PR good things like if they submitted a BLA. Regarding TLD, sure they have it but they wouldn't keep it secret if they are working w the FDA et al. Isn't the whole point of submitting a Journal article is to clarify and explain to the Journal audience, which the FDA et al is a part, the significance of DCVax-L TLD? Why would they submit TLD info to the FDA et al before that? It doesn't make sense to me.

And we all have theories on manufacturing. I'm in the they don't have a current contract w CRL for US manufacturing of 'L'; either because 1)they were tired of paying for dedicated space when they knew it would be a while for 'L' to reach the marketplace (and LP not having a vested interest in CRL like she did when she was paying for dedicated space previously) and/or 2) they'll resume w CRL once they start the BLA process. In the US, as part of the approval process, the FDA will do a pre-approval inspection prior to approving the BLA and that usually happens towards the end of the review process. Maybe that will be enough time to restart CRL DCVax-L operations, and/or 3) NWBO has been spotlighting Sawston. Perhaps they will be manufacturing for the US too. I feel like 3 is a strong possibility especially if they feel that Flashwork manufacture is ready for the big time.

Yes conjecture, and I really feel strongly regarding the BLA not being submitted (I'm sure they are working internally on it), but that's how I see it.