Replies to post #602823 on NorthWest Biotherapeutics Inc (NWBO)

[churchill_21]

Agree. It's standard practice to PR a BLA submission, not doing so after decades would be amateur hour to say the least. The only reason they would NOT submit a PR is if they truly believed they had a very slim chance of approval, or their BLA is a hot mess and they know it won't be accepted.

The fact they let their shareholders endlessly debate these basic operational items is such a joke.

[underpar71]

You mean Approval? PR for submission would be done before an acceptance. Then wait the 2-3 months for acceptance, assuming no additional docs required or questions from RA. Sounds to me that DI is speaking in tongues again. Somehow, some way, I am hoping they have been speaking with regulators and getting sections of the application in over the past year (rolling), so after MIA, there is little left to compile and submit for "final" application. If that is somehow the case, I would expect a quicker than usual acceptance as there would have been ongoing communication with our consultants and very little, if anything, to question. We just don't know. That is the problem. We can't even get a straight answer on what they plan to PR.

[biosectinvestor]

I don’t think “management risk” has anything to do with “weighing things down”. They’ve been successful against all odds and projections of the naysayers, repeatedly and over and over again. Timing of course is always one of the issues that some concern themselves with, but giving comfort on timing allows some to play games talking down the price while they invest elsewhere, etc.

Also, the reality is submission doesn’t start the timeline. Acceptance does.