Drano: The fact that the reasonably salvageable da

Drano: The fact that the reasonably salvageable data from the BLA for the HIV combo drug trial does not support the refiling of the BLA does not mean that there is necessarily insufficient salvageable data to construct a surrogate marker (endpoint) that would be reasonably likely to predict clinical benefit, subject to a confirmatory clinical trial, for patients with unmet medical needs. (And HIV MDR patients fall squarely into the unmet medical need category.) The above is the standard for accelerated approval of a drug pursuant to FDA rules and regs, and it is far less demanding than those for BLA approval pursuant to a phase 3 clinical trial.

As to arbitration damages, I strongly suspect that the consequential damages which have accrued since the Refusal to File date already massively exceed the sum of Amarex's malpractice insurance limits and whatever contribution to settlement that NSF (which apparently is not a named defendant in the supplemental claim referenced in the recent PR) may be willing to make to save Amarex from a forced bankruptcy (should the arbitration play out to a decision). Consequently, CYDY need not concern itself that any future LL revenue to treat HIV MDR patients, IF the FDA were to grant accelerated approval, would reduce the recoverable, collectible damages from any arbitration settlement or award.