Replies to post #253179 on NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Evaluate:

I stand corrected. I am wrong and you are right. I checked the 10-Q and it plainly states that approval is not required but that it is a good idea to seek regulatory guidance and comments on any new/modified SAP. If that is the case, NWBO is NOT handcuffed and TLD revelation is more in NWBO's control. Perhaps in the iterative process, comments were made and then incorporated along the way. That is how we did it with the FCC, another RA, when I was a regulatory attorney. Don't think the process differs much among these agencies. Then the "final" presentation was made on already agreed mods and final sign-off should not cause any significant delay. Accordingly, this is positive, I think that NWBO covered all the bases in a comprehensive SAP doc, and we should see top line, most probably in early 2020, before the ASM. I think that is a good bet. Certainly, well before warrant expiration.

Thank you for correcting me.

[biosectinvestor]

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.