“So if we don’t have manufacturing needed for COVID why
“So if we don’t have manufacturing needed for COVID why would the FDA give us approval (quickly)?”
Very valid question. The BLA portion for manufacturing hasn’t been submitted yet. CYDY currently has 10K doses for COVID patients per NPs statement this past week. But those doses won’t last long IF leronlimab is approved for COVID. I’m assuming that’s why he mentioned signing a new deal with Samsung this coming week. The 10K doses will be given to the most sick first (in the U.S) and then treatment will expand to mild/moderate patients in the U.S. and worldwide patients once more is manufactured.
The second question we should be asking is why would NP promise the first 10K doses will be free? CYDY is s pre-revenue biotech with a limited supply of leronlimab and a possible 2 months wait for more. Yes, NP mentioned the potential for a government grant, but he’s also mentioned $100m financing deals, deals with China, the BLA being filed soon (x 10) and so on without anything coming of those promised. I find it hard to believe that someone in the government is already discussing a grant for Leronlimab considering the trials just started and that there’s 100+ other trials for COVID treatments going on. IMO, NP shouldn’t have made a public promise to donate the 10K doses until a grant was 1000% confirmed.
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