Replies to post #366580 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Thank you for your detailed explanation. Even though I disagree with your rationale, I respect your opinions.

As you may know, I believe the following:

(1) NWBio received feedback, comments & buy-in from all 4 regulatory authorities (FDA, Health Canada, MHRA, and PEI).

(2). The FDA is the lead RA, and they were the first RA to provide feedback, comments, and buy-in.

(3) There is a strong company focus by NWBio, and by all 4 participating RAs, to provide patients with better & more effective treatment options for ndGBM & rGBM.

(4) NWBio is working directly with the FDA, and the other 3 RAs to Fast Track DCVax-L approval in all 4 countries.

(5) NWBio may be using the FDA's Real-Time Oncology Review (RTOR) & Project Orbis programs to Fast Track DCVax-L approval in the US, UK, Canada and Germany. Both of these programs must be coordinated with & spearheaded by the FDA.

[biosectinvestor]

The FDA would have given them a certain answer if they did not approve. And in that context I doubt the company would have proceeded without disclosing a clear rejection. They’d also likely be required to disclose given previous statements and the basis upon which they are proceeding and now the statement in their Annual Report.

Unless you’re alleging fraud, I see there to be no possible way that they have not been cleared to proceed. The FDA does not give an written all clear, generally, on an initial request to do a clinical trial including an initial SAP. Parties can request a specific thing called an SPA (a special protocol assessment) only at the beginning of a trial and they are not typical. Moreover, they are no guarantee either, on anything.

But the FDA will tell a party if they think a protocol change is inadequate or could not result in approval. They will raise issues, which a company can then answer. But there is no special “non-approval” applicable now that otherwise would not exist. Basically, they are in the same position they would be otherwise.

Lastly, this is not some surrogate measure of survival being offered to expedite the trial, for a conditional approval. They waited 14+ years in this trial to demonstrate actual survival numbers, so the entire argument is baseless. The only thing that would challenge the measure of actual survival would be if actual survival was false. I don’t see how that is possible.