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Friday, 07/28/2023 8:45:43 PM

Friday, July 28, 2023 8:45:43 PM

Post# of 731549
BTW - Regulators are obligated to halt a trial for futility. It's an ethics obligation and a violation, if it's not adhered to. So retrospectly, that puts DCVAX in the success column. In other words, to the FDA it's old news. But the challenge for all stakeholders has been the lack of a precedent to use as a reference to help usher in a complex modality. This ain't a microwave helmet. Plus, no one could have anticipated seeing the treatment "evolve exponentially" to the plus side, even before recieving an approval for the core product "FIRST?" Look at statins remaining flat for 25 years. So, imo, the timing of all these elements coming together, led to a decision to extend the timeline now, as a means to do more than just bookmark combo options, but to pre-approve those options instead, and avoid a drawn out process that was sure to come in the very near term. IMHO.

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