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Re: HappyLibrarian post# 579320

Wednesday, 03/22/2023 9:44:05 AM

Wednesday, March 22, 2023 9:44:05 AM

Post# of 698493
HappyLibrarian,

In case you haven’t noticed yet, NWBO takes the heat and even covers for changes made by regulators along the way. Remember Les coming out to say that enrollment didn’t change and that the SOC discrepancy was just an anomaly? Obvious covering for regulator intervention and the trial data integrity as it matured. Remember the increase in manufacturing expansion plans by Cognate and then Charles River Labs after NWBO would have seen confirmation of data indicating effectiveness in rGBM and talk of making this SOC? Or how about the UK law change regarding tissue import back in December of last year followed up by a second inspection at Sawston in February? Just a few situations of many including the project Orbis option etc. So no way NWBO is going to constantly point fingers at regulators, who are trying to catch up and control the final decision, just because investors have become impatient.
Changing the status quo and it’s support system requires a multi prong approach. Can anyone say Cohen and discovery? Next up is the CRL manufacturing agreement, probably more patents granted and BLA/MAA submissions. Thankfully a few more patients, still limited by funding, will now have access to the Specials Program due to the import license changes made last December to include immune cells. Go NWBO!; ). Best wishes.
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