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Re: lrdpdx77 post# 428811

Wednesday, 12/22/2021 12:58:58 AM

Wednesday, December 22, 2021 12:58:58 AM

Post# of 717973
This company is at this moment in an extremely unique position, with a very well positioned new immunotherapy technology that looks like it will potentially be efficacious with solid tumors of various sorts, IMHO.

Plus, as I have said before, people do not realize the incredible requirements set for the FDA by the 21st Century Cures Act, far beyond what people here are discussing or realizing in terms of speeding new treatments to patients, much faster than before. I think the DCVax platform will be a test platform for those new procedures. The FDA has been incredibly slow, but they can’t sit on their hands forever, as this is current law.

Getting this approved for other cancers, IMHO, under the new rules should be much faster and much easier than maybe is currently anticipated. BP knows this to be true, I believe. Doesn’t matter what posters on bulletin boards think or how far back in terms of legacy regulatory processes and ideas they need to dig up to suggest bad outcomes. Lots is happening in the background, at the FDA to advance those policies, even if the agency is understandably hesitant as Congress can pass a law to expedite and then individual persons in Congress and commentators can pretend they are outraged at a rapid decision that might seem controversial but is possibly just the agency trying to be proactive on the ideas in the new law.

Given the patient support for DCVax, I do not think that will be a problem in this case.


All IMHO.
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