Replies to post #66035 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Absolutely wrong. That has never ever ever ever happened. Regulators would never place a P3 trial on hold because the sponsor was not yet ready to manufacture on a commercial scale. Or because they haven't "validated" how the tech will be manufactured on that commercial scale. All those issues are addressed after P3 data. The sponsor can make preparations of course and should, but to say a regulator would step in and place a clinical hold on a trial because of that is so fantastically ridiculous. Good god. It's not a theory it's complete junk, shot from the hip by a clueless individual. Not nearly as good as giving all those super rare "Maurine" subjects "temalazoid," though eh master blaster?

The DCVax L P3 is on hold for not being A&WC in some way. Add 200-300 patients under a new design, or terminate the study and bury data and go chap 11 and funnel even more money to Cognate. Either is awful, but my guess is the latter is more likely.

[Doc logic]

flipper44,

That theory is a good theory for the positive outcome that aligns with the pseudo trial activity, the comments by Dr. Prins and Dr. Liau and the obvious build out of manufacturing. This is more than balanced out right now because of the current NWBO financial condition irregardless of cause, the silence irregardless of cause and past history of missed deadlines. For many this represents more than sufficient evidence that a positive near term outcome can not be achieved. Those who have been warning of this danger, whether eventually proven right or wrong about specifics, have been right to warn about the price direction. Buyer beware is a very necessary message no matter the source especially in this sector. With this said, I still believe the positives mentioned at the top of this post will have enough time to play out and I still plan to add to my position between now and the end of this year as timing and circumstances dictate and or allow. Best wishes.

[beartrap12]

Flipper, do you know of any other drugs/treatments that have had to prepare a whole new manufacturing method to go along with their new science that we can compare DCVax to? The closest I can come up with is Dendreon, which did poorly with manufacturing and may have encouraged the FDA to insist on proof of manufacturing ability.
We also know that NWBO was aiming for last February or March to complete manufacturing build-out in Memphis. I think Swanston is supposed to take longer, maybe another year or two. I think Germany is supposed to be ready. My point is that when the screening halt was instituted, we know their manufacturing wasn't ready, so it makes sense that they could be waiting on approval for their manufacturing process. I can imagine that it might take a few months for FDA approval of at least one site, maybe two.
So, if I can ask a question to make sure I understand: Does a company need proof of large scale commercial manufacturing ability before FDA will give their approval? I thought they had time after approval to get their manufacturing in order.
Thanks .