Replies to post #778964 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Slave, does NWBO actually have input during the labeling phase, or is it only the regulators reaching an agreement with one another.

Thanks,

Gary

[manibiotech]

Thanks 

[Slave1]

Your welcome 🙂

[meirluc]

" NWBO were still in the RFI (Request for Information) stage, NICE wouldn’t have used that specific language in the July letter. The RFI stage is pre-submission, NICE doesn’t yet discuss the absence of evidence at that level. But the July 15 letter explicitly states that “NICE has not received the evidence submission from the company at this time.”

Very solid answer but that makes me curious as to what language the MHRA
would have used in its July 15 letter if NWBO would have still been in the midst
of an RFI?

[Smitty5150]

I still dont understand why the language used by NICE in the 7/15 letter would mean what you are saying. To me, it just means NWBO hasnt submitted anything and cannot until MHRA approval. How you can come up with that the MHRA approved and just waiting on labeling as the final step is a bit baffling too me. I have communicated with the MHRA many times and each time, the wording used is different based on the Author...each person responding to my inquiry's uses a bit different wording in their responses, although they all mean to say the same thing. Not being difficult, as you are entitled to your own opinion and I can appreciate different perspectives, but I honestly don't believe it.