Replies to post #691962 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

if you are stating they need a C suite to get an approval decision on the original MAA.

I believe that we do agree that they are applying for MAA using the artisan method... and not using the Flaskworks' Eden.

I'm backing off my thinking that the validation was at receipt (despite having believed that to be the case back in early January!) ... the MHRA guidance site I was recently (meaning now, and not back in January) basing this thought on turned out to be for initiating a clinical trial, and not for an MAA.

My thinking is... and it's mine alone... is that the 1/24/24 validation was truly the validation and that the P1assessment began in earnest then... and if the P1 of the assess was, as your ChatGPT indicated (focuses on the administrative and procedural aspects of the application, such as reviewing application forms, data on the medicine's quality, non-clinical data, and details of the proposed labeling and packaging), then I'm leaning towards the 3/7/24 "confirmation of validation" marking the end of that process, and hence, the end of the P1 assessment. And even though the P1 assessment could have taken longer (80 days) it took less than 80 days and perhaps just 44 days (1/24 to 3/7 = 44 days). That seems more reasonable IF the P1 is solely "administrative and procedural" as the ChatGPT response you received suggested.

However, I could very well be wrong in thinking that, and I am likely alone in thinking that. My bet is that the company believes the two dates to serve as "bookmarks" to the beginning of the assessment period. By this, I mean that they probably think the assessment could have begun on 1/24, it could have begun on 3/7, and it could have begun between those two dates; therefore, I think they think it safest to go with 3/7 to mark the beginning of the 150 day assessment timeline.

For my part, however, the second "confirmation validation" simply makes no sense if its purpose was simply to confirm what was already confirmed on 1/24. It makes more sense to me that the second validation marked the end of Phase 1 - IF - the phase 1 truly covered what that ChatGBT response you received indicated.

Like you, I do believe that any inspections take place during the P2. I'm not sure if the RFIs mainly occur during a P1, and/or if they still can be issued in the P2 portion of the assessment.

Regarding this section...

And yet, the 10q drafters wanted you to know that while they were expecting inspection(s) to be scheduled soon, but none had yet been scheduled. This is such a critical observation, imo.

I don't think we know with certainty that they meant no inspections (or RFIs) had been scheduled by the time the Q was issued (May 10), or if they meant as of the first quarter. I wish that I was comfortable that remark meant as of the Q's issuance, but I'm not sure.

As to where we are, then, in the assessment process is for me still a big question mark.

• Did 1/24/24 mark the start of the P1 and then it ended a full 80 days later on 4/12/24, at which the P2 began and 70 days later would be at 6/21/24?

• Or did 1/24/24 mark the start of the P1 and it ended on 3/7/24, at which the P2 began, and then 70 days later would be 5/17/24 (tomorrow). However, if there were an RFI issued, or MHRA simply needed more time than 70 days, or there was a maintenance scheduled and any inspection needed to take place afterwards, or something else added on extra time... if it were an RFI, then POSSIBLY 60 days later would bring us UP TO around 7/15/24.

• Or if 3/7/24 marked the start of the P1, and 80 days later the P1 would end around 5/26/24. Then the P2 would begin, and if there were no clock off, 70 days later would be 8/04/24.

The next Q is due around 8/10ish... so at that time, we'll either have an answer to the MAA, or we'll get another update (was there an RFI clock off?), and go from there.

LG's Fall remark, though, I do not believe had to do with that season being the time they expect an answer to the MAA... although it still could turn out to be issued during that time (if the P1 of the assessment began on 3/7/24 and there ends up being a clock off). Instead, I do believe that the comment pointed towards a particular time when they might be able to finally speak to events (plural) in more detail that they can't really speak to now. So for my part, I'm taking the Fall comment to mean nothing to me as far as the timing of an answer to the MAA alone.

Hope that all makes sense.