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vator

07/28/25 10:08 AM

#778388 RE: Slave1 #778386

" Northwest Biotherapeutics is in the final phase of regulatory review, what’s called the labeling phase. That means they’ve already completed the scientific assessment and received the committee opinion."
Not wanting to be argumentative but how do you know this? You are a knowledgeable person but it seems like the labeling phase is speculative.
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manibiotech

07/28/25 10:13 AM

#778390 RE: Slave1 #778386

I specifically said updates about regulatory filings which they are planning , not the one under review. 
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seekinganswers

07/28/25 10:15 AM

#778391 RE: Slave1 #778386

Utter bull sh*t by Slave1 BOT.
"Manibiotech, I get the frustration, but let’s not misrepresent the situation. Northwest Biotherapeutics is in the final phase of regulatory review, what’s called the labeling phase. That means they’ve already completed the scientific assessment and received the committee opinion. What happens now is legal and procedural: negotiating the exact product label, prescribing language, and post-market conditions. At this stage, silence isn’t evasive, it’s mandatory."
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gwm61

07/28/25 10:54 AM

#778405 RE: Slave1 #778386

Hi Slave1,
You say the application is in the "labeling phase." Is it possible, to tell us what day exactly it entered this phase? ChatGPT says this phase lasts 2 to 4 weeks.
Best regards.
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barnstormer

07/28/25 2:36 PM

#778451 RE: Slave1 #778386

Slave, do you really get the frustration? Or maybe the question should be whether you understand the extent of it. Manobiotech has been a board member for about 10 years, and I have that beat by 3 more. Those years have been a ongoing litany of stops and starts, apparent moves forward only to run into delays, etc., magnified too often by a lack of information or communication from the company. If I didn't believe in the technology I would have left years ago. Finally progress to the MAA submission, followed by silence for a year and a half.
Since then, the process has reminded of me of that old football metaphor - the one where every time you finally get to the 5-yard line, they move the goal posts, or maybe the Chinese water torture would be more accurate. With no input from the company, we are left with a deluge information from sources pro and con, leaving the individual to sort through them as best he or she can to form an opinion.
Part of my frustration is that I'm 81 and time has become more valuable to me. I'd like to get some benefit out of this investment while I can get some enjoyment out of it. Is it going to take the same period of time to get through other regulators or has that need been minimized by the MHRA? Will management finally become more open to providing information and responding to questions? We can only hope.
Enough of my rant, I appreciate your which posts have been helpful in clearing the air.