Replies to post #789867 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

In normal course of events , labeling is included in 150 or 210 days pathway. So if there is no RFI pending , labeling shouldn't take months . 

[Smitty5150]

my guess and "feel" is we are indeed -3 months away from approval. The MHRA went/are going through this application with a fine tooth comb, but they didn't treat it any different than any other biotech that submits a application to them. Its what they do and its essentially their job to find things in the application that need/ warrant explanation, whether its NWBO applying or Biogen. Size of biotech doesn't matter, the MAA process is about scrutizing everything and see if the applying Company can answer the questions to the MHRAs satisfaction. There are no free passes no matter how many times we all have heard, from people on this very board, that approval would be quick and decisive. 500+ days is a long time, but not so considering the gravity DCvax will have in the oncology space. Both George Z and I agreed on this. This guy is very intelligent and has spent time in the scientific realm of biotech with some big players and was a sell side analysis for the big banks. He has seen both sides of the coin...the scientific and financial aspects of this space. One thing is for sure: He didnt strike me as someone who aligns himself with a loser, if you catch my drift.

I wanted to post this because there is so much misinformation going around. The specifics of my convo will remain with me. I suggest to anyone serious investor on this board, to stop listening to the many "talking heads" on this board, both bears and bulls, and get the facts straight from the source. I have read this board for a very long time, and not 1 prediction from anyone has turned out to be true...and trust me there are a lot of "predictions" that have been thrown around here over the years Its all a bunch of BS and truly goes to show how little, as retail investors, we know about the biotech space. Fortunes are lost and made in biotech because of it. Believe nothing what you hear, and everything that you see. The 10k and 8ks tells the tale.

[Smitty5150]

and just to confirm, George Z did not give me any specific info on what "phase" they are in. But you can gleam a lot of someone's disposition and thoughts just listening to the manner in which they answer your questions. Based off this I am 100% certain they are not in a labeling phase. Andrew and his AI speculation is steering investors down the wrong path. I have always felt this about his posts, but after talking with George it made me feel even it even more so. He might be a good weight loss doctor, but his wild speculation should make him lose almost all credibility when its comes to NWBO, and biotech in general. He is in way over his head, and the way he compensates for this is with his use of AI. He throws out a bunch of positive things and some longs gravitate to it likes flies on sh*t. Conformation bias at its best.....its the way the human mind works. We all want to believe someone who shares the same sentiment that we do. Its only human nature to do so. But he is just on another level and really misleading people with false expectation's, when in reality he has no idea about anything to do with biotech.AI can be a terrible thing for this reasons. My point: Be careful what and who you believe.

[sentiment_stocks]

This is what comes up on an easy Google AI search re: MHRA's labeling stage.

Does the MHRA wait until the end of an MAA application to work on the labeling?

Response:

Thinking
Kicking off 4 searches
Looking at 70 sites

No, the Medicines and Healthcare products Regulatory Agency (MHRA) does not wait until the very end of a Marketing Authorisation Application (MAA) to begin working on the labelling. Labelling and other product information are assessed throughout the review process, not just at the final stage.

Key aspects of the MHRA's labelling assessment process:
Initial Submission: When a company first submits an MAA, the application dossier must include draft product information, including the Summary of Product Characteristics (SmPC), labelling, and the Patient Information Leaflet (PIL).

Assessment and Communication: During the assessment procedure, MHRA assessors will review and comment on all parts of the submitted dossier, including the proposed product information. Any issues or necessary changes are communicated to the applicant, typically through a Request for Further Information (RFI).

Review and Updates: As the assessment progresses and questions are resolved, the applicant submits updated documentation, including revised product information, as requested by the MHRA.

Finalisation Before Approval: The product information, including the labelling and PIL, is finalized and approved as part of the overall authorization process. The final, approved text is what is then included in the official grant letter.

For certain accelerated procedures, such as the International Recognition Procedure (IRP), the MHRA may rely on product information that has already been approved by another trusted regulator, which can speed up the UK's assessment. However, even in these cases, UK-specific requirements for labelling must be addressed.

And that marries up with what Les had told me several months ago when the claims were first being made that we were in the "labeling phase". I had asked if the label was presented in the beginning with the application (as I'd read somewhere that the label was part of the application), and he had indicated this to be the case (and that is not some sort of big reveal as this information is out there, as indicated by Google's AI), and that the labeling was also addressed throughout the entire process, and not just at the end.