HEB has stated in several PRs that their NDA is supported by several (4?) P3 studies. Can anybody find what the studies are?
Those include all of the failed studies HEB has conducted on Ampligen in any indication. HEB has been searching for a decade or more to find some indication where Ampligen might work.
With CFIDS turn out to be the ticket? HEB itself evidently doesn’t think so, judging by the company’s decision to raise capital six days before the PDUFA date (#msg-37937719).
If FDA does approve Ampligen for CFIDS, it will be an even bigger surprise than the approval of VNDA’s Fanapt.
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