Replies to post #691352 on NorthWest Biotherapeutics Inc (NWBO)

[CaptainObvious]

Hmmmmm.... 🤔

[StonkMaster]

So many questions, so little answers.

We'll have to wait and see for now. Hopefully approval is sooner rather than later.

[exwannabe]

Why? It makes no regulatory sense. An maa evaluation clock day one does not default to the validation confirmation date. Ex is throwing sh_t against the wall.

We know that for the EMA it would restart the clock if a Request for Clarification was issued.

Scenario two (validation supplementary information requested)

. The applicant submits an application that is not in accordance with the Agency's guidance (see below: What are the main principles that my application should follow in order to pass validation successfully?).
. The Agency will ask the applicant via a request for Validation Supplementary Information (VSI) to submit the additional information, clarifications or corrections.
. The applicant provides the above additional information within the validation timeline. If the additional information submitted is as requested, the Agency will confirm the positive validation to the applicant.
. The scientific evaluation will start on the next available start date according to the Agency timetables.

So even if the MAA was valid, the EMA would reset the clock on a clarification request. And the MRA used to follow the EMA regs, so likely still does unless somebody can show otherwise.

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance

And no, I never said the confirmation date. It would be the date the RFC was returned by NWBO. That starts the clock at the next submission slot, Mar 4.