NorthWest Biotherapeutics Inc (NWBO)

[antihama]

My responses to you in red

There is no relationship between TLD and BLA. If you meant 'No legal requirement between the two then that's true but in practice a PR for TLD would come before a BLA is submitted Normally TLD would have probably been out many months, perhaps even a year ago, shortly before a presentation at a major conference. NWBO made the determination not to make such a presentation, they wanted the more comprehensive presentation found in a Journal which is rather uncommon, but perfectly legal.No argument here

Probably before they even received the data they were working on developing the team to put together the BLA. No doubt their were discussions with the regulators on how it was to be done No argument here. We still don't know if they're doing the rolling submission, or waiting to submit the entire document.I disagree w this part. A rolling submission is associated w an accelerated approval pathway be it a priority review or just fast track and we haven't gotten any PRs indicating that.

I'm not suggesting that I've ever heard of a complete BLA being submitted before at least TLD has been seen, I'm just saying that no rules are established that makes it impossible. I frankly cannot tell you if the regulators must publicize the PDUFA date No, they don't have to, or if they notify the company Yes, they do, and it's up to the company to announce it Yes, it's a company responsibilitiy, or if they choose, delay such an announcement Wouldn't that be considered material info for a tiny biotech with hardly any income whose tech would be a paradigm shift in SoC and would be required by regs to do so?.

If you believe that there is a benefit to the element of surprise, you delay everything that you're not required to announce. I believe the company made the decision to get everything they could done before it became public. I don't know that they can get the FlaskWork unit qualified, but I feel confident that they're working on it.

Is it possible that the BLA is submitted before the Journal is published, why not? Not saying this is the case, but nothing prevents it Well yes, the way it usually works is the BLA is submitted before a publication but TLD released before the BLA submission and that's why I believe the BLA has not been submitted. Have they had discussions w the RAs and believe they are dilegently getting the BLA together? Yes, but as to submitting a BLA, it would be crazy not to PR that..

IMHO