Replies to post #414965 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The Lancet article and FDA draft guidelines on external arms should be a clue it’s not the FDA’s stance on endpoints causing delay. If that wasn’t enough, then perhaps the real world data draft guidelines just published would win your confidence. No? How about the head of Orbis saying any new SOC needs capacity for rapid manufacturing expansion. No? How about the MHRA caseload delay? I mean, the endpoints? You think this wait is still on endpoint acceptance? Come on, they locked the data a year ago. That’s when you go with the endpoints.

[foxhound02]

I agree with you 100%. The delay is not about the trial; it is about endpoints. I have stated this before.

[MI Dendream]

Gus, I don’t think we are waiting on FDA to approve the new endpoints. That process started three years ago and even if NWBO has mastered the art of dragging ones feet, FDA actually moves faster than that. I honestly believe that if the NDA process has not begun, there is only one person to blame and her last name is not Liau.

However, I believe that progress has been made and we are about to see a can of whoop-@ss opened up on shorts. I have just been wrong about timing so many times before that my faith is skin deep. I think competent or incompetent management aside, DCVax is worthy of Billions in market cap. How many billions is the question?

If LP has mastermind a series of positive news including regulatory news beyond UK manufacturing certification, then this could be a very large number of billions. If not, I still think we see at least $4 which is $5.5B market cap. Still a big win for most longs, but one that doesn’t make up for the opportunities I missed out on. I will be a disappointed investor, but I will get over it.

[biosectinvestor]

I have mentioned a regulatory final issue. My point has absolutely nothing to do with endpoints. Nothing.

I believe the endpoints are not controversial and fully approved, by all regulatory authorities. I have explained that the FDA, will all endpoints for all companies no matter when they were proposed, at the very beginning or revised, can always reserve the right to update its view, even with an Special Protocol Assessment, which is explicitly supposed to be a way to avoid that, and even then, it’s no guarantee they won’t change their mind. I do not believe that applies here, because OS is the actual gold standard. There is not a higher measure of success.

So that’s my view in that point.