I could be mistaken, but I believe the relationship between Dr.NP and Dr.BP might have become strained before the FDA issued the RTF. And it seems the FDA would only have been able to articulate their issues with the ROT in the context of the RTF.Quote:The cydy/incelldx honeymoon was on. Except along comes the BLA and the FDA shoots down the Receptor occupancy tests.
Also, my impression is that the FDA's issues with the ROT were centered around consistency concerns across the patient population over time -- rather than necessarily a material defect with Dr.BP's ROT test. I seriously doubt IncellDX's ROT's are/were fundamentally defective. Of course, I could be mistaken on all counts.
Lastly, let's not forget that it was months later before we learned this incredibly important fact. We investors were initially spoon-fed an incomplete description of the scope of the RTF that included only two issues that were described as easily remedied because CytoDyn already had everything they needed to resubmit the BLA. More specifically, we were told about labeling issues relating to bundled 3rd party syringes and the need to include a CD-03 Mono Integrated Assessment.
I'd be willing to give CytoDyn the benefit of the doubt that maybe they did not learn of the FDA's rejection of the ROT until months after the issuance of the RTF. However, prior to the Type A meeting where they might have learned that fact, shareholders had already become quite vocal during conference calls asking why Dr.BP was no longer involved and why he was not being invited to participate in the Scientific Board of Advisors. When Dr.NP finally got around to telling us that all of the ROTs had to be re-run, he seemed to be using it to disparage or discredit Dr.BP -- in order to explain his absence from the company.
I think none of us are served by regurgitating the alleged friction between Dr.NP and Dr.BP. My only point is that if CytoDyn only learned of the ROT problem months after the RTF, then the thesis regarding it being the genesis of their failed relationship (which became apparent months earlier) becomes even more tenuous in terms of timing.
Enough said. It is certainly an unfortunate chapter, but we have much to look forward to.
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