Quote:

---

I really do think the FDA knows Leronlimab works and is safe, but they also do need the data (properly formatted, etc.). If we provide exactly what they ask, I don't believe they could justify continuing the hold when it's so clear this drug holds enormous promise. If Leronlimab becomes a famous, game changing drug down the road, the FDA's only excuse for holding it back could be they didn't have the right data. Mgmt is about to give them precisely that, so I'll be surprised if they want to prolong their sandbagging for much longer.

My prediction is hold lift by Halloween, worst-case Thanksgiving.

---

For me the biggest questions/ concerns are:
1. Did management receive any useable HIV and safety data from AMAREX?
2. What has AMAREX really done over the last years with all of our trials (cancer, longhauler, NASH, ...) ? In other words how much more did they screw us?
3. What is the quality of this data and what mess did current management discover in the last 6 months? Can any of the data be used?
4. What if AMAREX fu%/ up our HIV trial, beyond any chance of successful BLA?
5. How will FDA look at any AMAREX trial data if they know how incompetent and clueless AMAREX is?
6. Is anything trustworthy what AMAREX touched in the past?

I hope we get a clear statement about the AMAREX case and an information about what is going on with the HIV trial data in the end of September. They had 6 months to analyze the data.