The FDA rejected LL's mTNBC for BTD and the SEC and DOJ are investigating the company for "false and misleading" data reporting. Dr. K's spinning of data -- was supposed to be a Phase 1 dosing trial among naïve mTNBC patients. What was reported with a mash up of the Phase 1 trial and the heavily treated R/R mTNBC data -- a different indication. Then to make it more confusing he used an unvalidated "model" and wild headlines of 360%, 680% improvement -- Hunh?? That isn't a oncology metric -- ORR, OS, PFS, individual patient data is was is routinely reported. Not Cytodyn -- the most convoluted data report I've seen in cancer. So deceptive that the SEC and DOJ have no added it to their investigation.
NP claimed they just needed to call patients to get more data. Really, what kind of well-controlled trial is that?? It was a con as the FDA formally rejected the BTD application and the company would have to totally reapply. Doubt that is going to happen as the mash-up naive/heavily treated R/R.
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