Replies to post #817920 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Your argument is still speculation stacked on speculation.

First, you admit there is no way to prove that a pre-BLA meeting occurred or what FDA said if it did. That should end the claim right there. You cannot turn the absence of proof into proof of a negative. There are no public facts showing that FDA told NWBO not to file, that FDA rejected the data, or that LP was trying to avoid hearing FDA’s views. That is conjecture, not evidence.

Second, your premise that a pre-BLA meeting would necessarily have been some decisive “go / no-go” event is wrong. FDA describes a pre-BLA meeting as a discussion of the proposed content of the application, major unresolved issues, and plans for submission. It is not described as a public thumbs-up or thumbs-down on ultimate approval. So even if such a meeting occurred, your theory about what FDA “must have said” still does not follow.

Third, the idea that NWBO should have “started resolving issues back in 2020” assumes facts not in evidence. You do not know what discussions may or may not have occurred, what issues may or may not have been identified, or what regulatory sequencing the company chose. What we do know from the public record is that NWBO was preparing a UK filing well before submission: on August 29, 2023, the company said it had completed prerequisites for the MHRA application and expected submission in roughly 30 to 45 days, and on December 21, 2023, it announced that the MAA had been submitted on December 20, 2023. That is a planned path, not some panicked last-minute pivot because of an unseen FDA disaster.

Fourth, for a personalized cell therapy, regulatory sequencing is not just about picking the biggest market first. It is tightly tied to manufacturing, logistics, and jurisdiction. NWBO’s UK filing fits with its established UK manufacturing infrastructure, so your “why wouldn’t they” argument ignores a major real-world consideration.

Fifth, the “radio silence” point is also overplayed. Confidential FDA interactions are confidential by default. FDA’s formal-meeting framework does not require public disclosure of whether a meeting occurred or what was discussed. So silence on that point is not some extraordinary red flag; it is entirely consistent with the normal regulatory framework unless the sponsor chooses to say more.

So the real bottom line is simple:

you are not pointing to evidence of an FDA rejection.

You are pointing to an absence of public disclosure and inventing a story around it.

That is not due diligence. That is narrative-making.

[Doc logic]

exwannabe,

Too much subjectivity tied to a final decision at FDA especially with influence that could be tied to questions about ECAs even though they were checked down in for bias with none found. The bears really have pushed hard on this which tells me that is where big pharma influence would like their influence to gain the upper hand during any FDA consideration. I mean the mob knows that you go after the juries to avoid justice because they are the decision makers. No different with big pharma.
May 10th 2022 should have been enough to convince anyone decisively that seeking UK approval first then going to the FDA is the best route even if most don’t understand the difference between the U.S. and UK with regard to acceptance vs approvals of SAPs. The Europeans put a heavier emphasis on upfront manufacturing preparedness than the U.S. does, though, so getting that squared away first is one of the top priorities. Having manufacturing that works for business profitability when reimbursement rates are typically lower than in the U.S. is a NWBO priority.
There is also a push for closed system manufacturing due to increased risk of contamination from open processes and profitability concerns. Whether this push is more from regulators or just necessity for NWBO can be debated. What is not debatable is that this is the direction that NWBO has chosen with no other plans for artisan expansion on the table. This fact alone as well as the time involved for an approval decision points to the importance of Flaskworks manufacturing even though regulatory issues are extremely important as well with regard to reimbursement rates and hub and spoke manufacturing.
Bringing leukapheresis capacity in house also demonstrates the need for non external capacity being required for MAA approval otherwise the capacity would have likely been initially carried by outside contractors to keep up front ramp up spending down. Leuk center capacity is limited in the UK and has been for a while but has started catching up to current and anticipated need, just not fast enough. In house leuk capacity was likely a requirement for MAA approval or cash strapped NWBO would have gone a different route. This all points back to manufacturing capacity and ramp readiness for initial demand and the planned move to Flaskworks from artisan. I believe this requires that Flaskworks be far enough along in the development process for approval to occur. Leuk capacity increases when manufacturing is expected to increase. If the increase from initial readiness is being covered 3 months in advance as is often typical then today’s job postings represent a significant demand increase over and above initial demand being met elsewhere in about 3-4 months; ). Best wishes.