No mention of accelerated approval, but they could be sitting on that maybe.
FDA guidance recommends that confirmatory trials be underway at the time an accelerated approval is granted. But since guidance does not carry the force of law or regulation, the FDA has limited leverage to ensure the trials are initiated at that time
Yeah - that's not entirely spelled out in the new Cel-Sci report document. However, I am guessing that they can get enrollment done much more efficiently than they did with that previous trial. Man that was a train-wreck last time with the CRO issues that they had. n
They should be able to get the tumor shrinkage and biomarker data under their belt rapidly. I suspect that they should be able to get enrollment relatively rapidly now as well with the existing supporting data. But survivorship data is just going to take the time to get it done.
They might go fishing for a partnership with a big pharma - or perhaps get a buyout offer on the table? As de-risked as Multikine is at this stage, some big oncology pharma might make 'us' an offer.
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