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Thursday, December 28, 2023 10:09:02 PM
But the Specials program is not ILAP. It is merely a hint of favorable regulatory disposition toward the company and product. Do you or any person honestly believe that they would allow the licensed commercial manufacturing of and sale of DCVax-L to deathly ill citizens if the regulator believed that the trial was a failure, and the treatment has no potential benefit to citizens at all and any claims to suggest that are fraudulent? I don't think so. I think they protect their citizens quite carefully. A few years back, Apple made some claims that others questioned about their computers and the UK prosecuted them for it. Of course NWBO can't make any claims or do any marketing. The prescriptions come directly from doctors. It's not the same as already being approved, regardless of what others say. They still need to go through the full process of review and approval. I do not anticipate that the would fail, given what we know generally, but that's JUST my personal opinion and everyone should make their own conclusions. Given reality, of course, anything is a possibility.
As for ILAP, I've followed that program for a long time. There is no other accelerated program of which I am aware that has that kind of timeline. DCVax-L clearly fits within the qualifications to be considered for ILAP. There is no specific time that you can or can't apply. Applying earlier is better, but these guys were already done with their trial when ILAP started as a program. I think they might be entering later in the program and these programs are intended to assist companies all the way along. But the accelerated 150 day approval process was proposed as part of the ILAP program, which was created to replicate what they viewed as the efficient approval process they went through in recent emergencies.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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