The following was posted this on SA:
I listened to the meeting 2nd time. I want to emphasize 4 things I feel many people missed:
1) On August 14th Cytodyn applied for fast track approval to MHRA(=UK FDA). The MHRA responded on August 24th: "We have REVIEWED(!!!) your request and are sending your request to senior management team in LICENCING(!!!) division for further input... "
After that, they got an update on 27th from MHRA:
"MHRA is granting a 1-hour tele-confenrence to discuss ROUTE TO MARKET(!!!) for leronlimab in the UK..."
Amarex said this meeting is equivalent to pre-BLA meeting with FDA and MHRA is requiring BLA submission package ESPECIALLY regarding MANUFACTORING(!!!). Cytodyn will review the package which was prepared by Amarex and submit it by Friday.
Pay attention to those words boys and girls. I think LL passed safety&efficacy requirements from MHRA, September 9th meeting will be about manufacturing and licencing!!!
Finally NP said: We have a STRONG CASE for fast track approval.
2) NP said: "FDA indicated decision is FORTHCOMING(!!!)".
That means FDA did not reject and they are seriously considering EUA approval. Sure they are moving slower than we hoped for, but I take "decision is FORTHCOMING" rather than straight rejection any day all day.
3) They will apply to UK for HIV combination and MONOTHERAPY. Correct me if I'm wrong, but currently there is NO monotherapy drug against HIV. Monotherapy market is 3-4 times bigger than the combo market and worth about 7-9 billion yearly.
4) Daniel Adams from Creative MicroTech said "My company specializes in blood based biopsy. In the past 10 years we have focused specifically on the communication aspect of the tumor cells and protumorigenic macrophages... Encompassing a few hundreds different cancer patient subtypes, CCR5 is expression is the most common both in circulating tumor cells and protumorigenic macrophages... Based on the previous hundreds of cancer patients (if not THOUSANDS(!!!)) across broad range of cancer subtypes, without the context of Leronlimab, PATIENTS WITH DIMINISHED CCR5 EXPRESSION is ALWAYS(!!!) associated with FEVER MIGRATORY TUMOR CELLS AND BETTER CLINICAL OUTCOMES(!!!). Our models have clearly shown that treatment with LL will PREVENT FURTHER PATIENT PROGRESSION
