I received a direct message regarding my theories on the possibility that accelerated approval may be under consideration. The author offered a variety of counter arguments, including the unavailability of a suitable surrogate endpoint and the historical absence of any accelerated approvals from the FDA for HIV drugs, but the most compelling was reference to the FDA approval last January of Lenacapivir, a Gilead capsid inhibitor, specifically to treat MDR HIV patients.

As I acknowledged from the get go, accelerated approval is only available to treat patients with unmet medical needs -- so the approval of Lenacapiver appears to close that path for LL. The FDA PR for Lenacapivir noted that it "may help patients," which doesn't sound overly positive, and our CC did include the curious comment that CYDY would be submitting info to the FDA on 5 different HIV patient sub populations. So even though Lenacapivir has been approved for the MDR population, could it be that a sub group of that population still has an unmet need? Any insights from ohm and any of our other best qualified medical/science minds would be welcome.

I'm not happy about this negative development regarding my accelerated approval posts, but recognize that maintaining trust requires that I share it.