Replies to post #611822 on NorthWest Biotherapeutics Inc (NWBO)

[dmb2]

hyperopia, I agree and am hard pressed to believe they are not involved in a rolling review given their special status with MHRA dating back several years unless there is a technicality such as a tight timing commitment for submissions they did not feel they could meet.
I believe, as you mention, it is the CMC, primarily the mfg development work and subsequent validation and comparability work that has held up the final section submission.
A rolling review process is ideal for both small entities such as NWBO and also for MHRA to work with them. Either way either the MAA final section or complete submission is close and I think we don't hear until it is accepted though I would prefer to hear sooner.

GLTA

[biosectinvestor]

Exactly, this is the post I was agreeing with earlier and by mistake replied to another. I think they are likely in process already in ILAP, most likely, and a rolling review is very likely.

Now it may be that there are variations on this process if a company wants to submit to multiple jurisdictions at once and utilize the various programs that the UK is a part of, which can include the Access Consortium and/or the introduction to Project Orbis, though Les’ appearance suggests they may have a separate plan to approach the FDA directly for approvals so Project Orbis may or may not be immediately on the table.

But the Access Consortium could also expedite a larger market access.

I said long ago I thought they would want to validate the automated manufacturing prior to approval because it is easier to do it that way, still lots of work, but easier than if they did it after the fact.

So I think we are very much similar in our thinking.

[NotSure2]

The UK paediatric investigation plan (PIP) compliance check (CC) should be performed 60 days before the submission.

I am wondering if they meant to say: At least 60 days before the submission?

The other thing is why NWBO would not announce it?

"there is something positive here, but we wont tell public, because we want our price share to remain as low as possible"

I must be missing something. Hopefully you are right, and I am wrong.

[antihama]

I hope they are on rolling review but I don't believe it based on the fact that other small biotechs have PR'd the beginning of rolling review and completion of rolling review i.e. submission. At least the market doesn't believe it or we'd have a higher share price.