Replies to post #425708 on NorthWest Biotherapeutics Inc (NWBO)

[CaptainObvious]

You meant TLD, correct? Data lock was announced last year.

[FeMike]

He meant data lock.

NWBO explicitly stated they will not lock data without SAP buyin from all 4 agencies at I believe the 2018 ASM.

Now, whether that holds any weight, who knows. NWBO also explicitly stated deadlines for TLD that they have missed no less than 4 times. And they also explicitly stated they expect to be certified and manufacturing DCVax in Sawston by Q3 ‘21. So they aren’t above just completely lying to shareholders.

[exwannabe]

Only one RA, the FDA, has a rule that they must provide a non-bonding opinion on the SAP.

The FDA may or may nor have accepted the protocol changes as being safe and ethical,

The PEI and MHRA have accepted a protocol change as being safe and ethical. That is the only known fact. It says nothing about their opinion on the change being suitable for approval.

That NWBO will not simply come clean and tell the full story is telling, They use the social media army to pump garbage,

[dennisdave]

its a true statement and for the following reason.

It would be of a tremendous utmost extreme stupidity to lock the database without discussing with the FDA their stands on endpoints change. If the FDA advises to do some parts of the amended SAP differently than then that is very difficult to adhere to after the database has been locked already.

Second. Despite as what others (ex) may tell you. Its no big deal to change endpoints / adjust SAP with the FDA prior to datalock. The only rule the FDA will impose is the employees/staff involved in the SAP adjustment must be objective.
Go ahead and Google FDA policy towards endpoint change/ SAP adjustment prior to data lock. You will notice it is as I described.

Third. Its well known that any biotech with any meaningful clinical trial are in regular discourse with the FDA especially when it comes to SAP adjustment. If the FDA would have advised against the change IMO that is a material event ans must be disclosed

[biosectinvestor]

The company did indicate that they would proceed with data lock when all 4 agencies accepted it. The SAP as far as I can see, is consistent with the policy aims of the FDA for trials exactly like this one.

I believe all 4 have accepted the SAP, but the FDA has policies that they are implementing that are all about advanced and adaptive trials for biologics like this, pursuant to the 21st Century Cures Act that are still in the process of being implemented and likely, given the many changes at the agency and the almost complete focus on the pandemic and challenges with the pandemic, the FDA seems to be moving quite slowly. Things that they have had in draft form for very long, and for which long ago they received comments, are still waiting to be made final policy and fully actionable. I'd actually wish the opposite were the case, given how many trials are on pause because of the pandemic, and there are very many, that the agency would therefore be using its staff in various efforts to get ahead on these many initiatives, but the reality is, they are out front on many issues, establishing thought leadership discussion, for instance on historical data related matters, and given the focus from all of the partner entities and the disruption of the pandemic, it just seems that the FDA's efforts are still going quite slowly. That is all IMHO.

That doesn't mean that it all won't come together at once, NWBO is perfectly situated IMHO when that occurs, but it does mean that the FDA while looking to be a good partner with innovative companies exactly like NWBO, is still a very bureaucratic place.

[newman2021]

It is true. In fact LP said that in one of the ASMs. Evidence is how comes UK and Germany (more than one regulator among the 4) uplisted the new 6 endpoints on their clinicaltrial registries? Where do the new 6 endpoints came from other than from the modified SAP? The shorts better cover ASAP before they lose their shirts.