I do believe this is good news. It can put pressur
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Posted On: 06/29/2020 7:15:24 AM
I do believe this is good news. It can put pressure on the FDA to not waste time, which could let Mexico be the first country with access to the “limited” amount Leronlimab being produced thus year. But I got to wondering about potential negatives surrounding the Mexico trial, too.
What if they do manage to get approval before the US? Maybe the speed of the small trial and some typical delay in data gathering or analysis here in the US flips the order. Do we start shipping vials for Mexico? We should, right? There are no guarantees of FDA approval unless there’s some behind the scenes discussions and handshakes we aren’t privy to. But that limits the amount of vials available for the US. It also means we wouldn’t be able to fulfill demand from any other country. Not that we realistically, or at least sufficiently, can either way with only 1.5 million vials set for this year. Can we produce more?
I don’t recall the exact video or call, but I seem to remember NP stating that Samsung could ramp up this year to something like 2 or 3 million vials if needed. He may have even said 5. This was months ago. He basically said that should the need exist, within reason because they can’t make an unlimited supply, they could produce a LOT more. I hope this is the case. That gaining approval initiates a plan already in place for Samsung to increase the order significantly.
I also briefly wondered if there was a correlation between the unblinding interim analysis yesterday and the signed memorandum today. As in, maybe they were unhappy with the p value of the primary endpoint and figured they needed a plan B. But the good news is that upon thinking about that for a moment it makes no sense. If 51 patients didn’t show significance than why would 25? In other words, I ultimately see this as both pressure on the fda as well as a smart, fast way toward additional approval if needed for any reason. Could be a slow or corrupt fda. Could be that it just lends credence to the story. Approved in multiple countries would sound great!
What if they do manage to get approval before the US? Maybe the speed of the small trial and some typical delay in data gathering or analysis here in the US flips the order. Do we start shipping vials for Mexico? We should, right? There are no guarantees of FDA approval unless there’s some behind the scenes discussions and handshakes we aren’t privy to. But that limits the amount of vials available for the US. It also means we wouldn’t be able to fulfill demand from any other country. Not that we realistically, or at least sufficiently, can either way with only 1.5 million vials set for this year. Can we produce more?
I don’t recall the exact video or call, but I seem to remember NP stating that Samsung could ramp up this year to something like 2 or 3 million vials if needed. He may have even said 5. This was months ago. He basically said that should the need exist, within reason because they can’t make an unlimited supply, they could produce a LOT more. I hope this is the case. That gaining approval initiates a plan already in place for Samsung to increase the order significantly.
I also briefly wondered if there was a correlation between the unblinding interim analysis yesterday and the signed memorandum today. As in, maybe they were unhappy with the p value of the primary endpoint and figured they needed a plan B. But the good news is that upon thinking about that for a moment it makes no sense. If 51 patients didn’t show significance than why would 25? In other words, I ultimately see this as both pressure on the fda as well as a smart, fast way toward additional approval if needed for any reason. Could be a slow or corrupt fda. Could be that it just lends credence to the story. Approved in multiple countries would sound great!
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