Replies to post #789351 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

AllSheWrote,

I think you have MHRA confused with a potentially compromised FDA that allows for more subjective decision making. MHRA would have voiced concerns early on to NWBO if they thought the statistical analysis plan was amiss. Instead they actually published an approval of it while the FDA only “accepted” it as a potentially approvable plan. Linda knew this was how the process worked BEFORE submitting to any regulator. Approval of the SAP by MHRA mitigated the chance of ultimate rejection of the MAA by MHRA based on that. That’s kind of important for a cash strapped company to be able to depend on BEFORE investing any more time and money into final preparations for approval with manufacturing upgrades, new employees and other infrastructure on the way to a final MAA decision. That’s called risk management and Linda is really good at this which is why Cognate and Advent were held separately for so long; ). Best wishes.

[seekinganswers]

"As a prudent investor"

WHAT??????? 🤣

[10baggerz]

Yes, I've considered that many times. Not only would NWBO's inability to provide requested patient level data render such an RFI a material event, but the MHRA would NEVER allow for an RFI to sit unanswered for over a year because there are LAWS about the amount of time every company has to respond to an RFI.
IMO is much more likely that the MHRA and NWBO are "working together/actively engaged" as both the parties have repeatedly stated in writing. Combined with the legislative backdrop and the company's acquisition of Advent for pennies on the dollar and accompanying written statements implying that approval and substantial scale up in manufacturing are the reasons for the acquisition, my wee brain tells me that the approval you call a "miracle" is far more likely than not.

No matter how many times that you repeat the "regulatory stealth rejection" theory, it remains one of the least likely bearish theories and really makes the time you spend here 24/7/365 seem more like paid FUD than altruism... but you already knew that.