Replies to post #253185 on NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

you wrote:

A lack of comments after a given number of days IS Approval. I guess you did not understand that this has been discussed for many months.
The same “approval” process applies to INDs.
Don’t assume they will not have any comments if they don’t want to make them, and as with an IND, lack of comment/approval does not actually mean the FDA agrees, until it sees the data, or, prior to an actual trial a company gets a special protocol assessment, which ALSO is not an actual guaranty that they agree ... These agencies always reserve all options to themselves.

I think your first sentence might be incorrect.
Perhaps you meant to say: A lack of comments after a given number of days IS NOT Approval.
Say that the FDA has 30 days to provide comments, and they provide no comments .... then this does not mean that the FDA has now APPROVED the Draft SAP.
Rather, in that scenario, the FDA simply provided no feedback, leaving NWBO in the dark as to how the FDA might act once the trial is unblinded and the data are evaluated as per the SAP.
For example (extreme example): if the Draft SAP looks to change the First Endpoint to OS, and the Second Endpoint to "Long Tail analysis" and delete the PFS analysis, but include other subgroup analysis .... then it would be great if the FDA takes a look at all these proposed changes and says "all that looks fine to us". However, if the FDA provides zero feedback .... then they are "reserving all options to themselves" to react as they might desire after unblinding and running the data against the SAP.
So .... the FDA would NOT be providing their approval by staying silent about the Draft SAP prior to data lock & unblinding. IMO