Replies to post #349285 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Almost word for word how I would describe it Simone. :)

My only additional qualification is that the FDA actually accepts the first SAP on the same terms. The only way you get anything better is with a Special Protocol Assessment (an SPA) which is like an agreement with the FDA that they will try very hard now to agree, at the beginning of the trial only, though there is no guarantee they won’t change their mind at the end or at any point later.

No real guarantees with the FDA ever. But they try hard. It’s not on purpose. They want to keep their mission of safety and quality at the top of the considerations.

[Kaizenman]

Umibe5690: "...is that the UK, Germany(EU?) and Canada have accepted the latest endpoints..."

It seems many have posted on this MB about concerns with final FDA approval. I am not sure how to assess this risk. Thus, I did my enterprise value computation on just UK and Germany approval and use for DCVax-L only. Even my relatively conservative estimate of EV is several orders of magnitude higher than the current value of NWBO.

The scenario that appears to be the most likely is UK and Germany approve first (possibly even under a EUA) and the FDA will decide several months after UK. (Note: Quick UK approval is highly possible due to the changes and high priority of novel therapies upon Brexit. Please search this MB for discussion on this topic),

Upside kicker #1 is statistical significance is shown for both r/n GBM. I did not factor both in my computation.

Thanks for relaying the call info!

[10baggerz]

Thanks so much Umibe!
Hard for me to fully “buy-in” ;) to management’s reasoning that keeping the wrong trial SAP on clinicaltrials.gov is somehow better when the correct SAP is already listed in Europe, but I do understand the point.
I do think what is being conveyed to pretty much everyone is far more likely than any argument that the FDA has rejected the new SAP and NWBO has somehow decided to proceed with a split SAP anyway. But that is the FUD that management created with this decision, so I decided to add some shares this week ;)
GLTA

[exwannabe]

The endpoints are defined in the trial protocol within the IND. The SAP clarifies details of statistical analysis.

The protocol is a formal document. There is no "maybe" in it. The trial investigators have a signed off copy that they are legaly bound to comply with. When submitted as an update to the IND, it becomes formally active in 30 days unless the FDA says no.

The "buy in" is a different issue. When the FDA allows an endpoint change, that does not say the new endpoints would be suitable for approval. It just means the new protocol (and trial IND) is still ethical to run. But, the FDA will provide a non-binding opinion on the suitability of the change in a P3. It is this opinion that is "buy in".

Every trial (at least those w/o a SPA) is the same. They have endpoints defined in the protocol that are published in the clinical trial registries. When updated, they are generally updated on the site. There is no BS about not doing so because of some "buy-in" garbage.

NWBO stopped updating clinicaltrials.gov for this trial over 4 years ago. They have not updated the status, expected number of patients or estimated primary/final completion. NWBO has a reason for not doing so, and it is not any "abundance of caution".