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Posted On: 08/07/2020 8:30:44 AM
Post# of 148908
saltz has a very good post on the matter worth a read
This quote is telling.
“COVID-19 Phase 2 topline report to be submitted for consideration of emergency approval of leronlimab for patients with mild-to-moderate symptoms to U.K. and other countries following submission to the U.S. FDA next week”
Let’s think like the company. They have known the meat of the topline
report for weeks. As soon as they know the COMPLETE topline report they are on the clock and must disclose the topline report to the public within three days. With the announcement of the submission of the topline report to the FDA next week it would seem logical that the results have been digested for weeks.
It would make no sense to submit the topline report to the UK and EU countries if the data wasn’t strong enough to warrant approval. CYDY’s concern is that the FDA may look at the report and say great data but we want to see a P3.
This is like a full disclosure let the world weigh in on the value of Leronlimab in both the Covid and HIV Combo space. Given the SOC how does Leronlimab stack up given the trial data. We think the data is strong enough to garner approval. We don’t want to take the chance of being pigeon holed and delayed by the FDA.
Bottom line is the topline report has to be compelling enough to warrant replacing current SOC. If Nader is stupid enough to make this move w a marginal report he needs to be replaced. This takes serious balls backed up by a strong readout.
Game on and coming fast as in any day next week.
This quote is telling.
“COVID-19 Phase 2 topline report to be submitted for consideration of emergency approval of leronlimab for patients with mild-to-moderate symptoms to U.K. and other countries following submission to the U.S. FDA next week”
Let’s think like the company. They have known the meat of the topline
report for weeks. As soon as they know the COMPLETE topline report they are on the clock and must disclose the topline report to the public within three days. With the announcement of the submission of the topline report to the FDA next week it would seem logical that the results have been digested for weeks.
It would make no sense to submit the topline report to the UK and EU countries if the data wasn’t strong enough to warrant approval. CYDY’s concern is that the FDA may look at the report and say great data but we want to see a P3.
This is like a full disclosure let the world weigh in on the value of Leronlimab in both the Covid and HIV Combo space. Given the SOC how does Leronlimab stack up given the trial data. We think the data is strong enough to garner approval. We don’t want to take the chance of being pigeon holed and delayed by the FDA.
Bottom line is the topline report has to be compelling enough to warrant replacing current SOC. If Nader is stupid enough to make this move w a marginal report he needs to be replaced. This takes serious balls backed up by a strong readout.
Game on and coming fast as in any day next week.
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