I don’t see a full approval first. I see a EUA for just one indication of Severe to Critical. I believe that in order to get a full approval across all indications. 1) We will have to complete another trial like Long Haulers with great information gleaned from the trial. 2) Have a huge increase in manufacturing will also be critical to an open label across all Covid indications.
The FDA has already spoken to that as a reason they would not consider us for Mild to Moderate. Too little product to spread to other indications. So manufacturing is everything and hopefully they are behind the scenes helping by just approving bioreactors at Samsung’s new expansion facility. That would be huge if the FDA could speed the process of manufacturing for Leronlimab by approving more bioreactors at Samsung or possibly AGC too. AGC has their new purchase of a large facility they purchased in Colorado and is needing bioreactor approvals for us and others to ramp it up for production. If that was happening behind the scenes by the FDA or OWS pushing the FDA. We might not be limited in manufacturing. That is our biggest issue going forward and the FDA should be prioritizing it either now before approval or realize that it must be accomplished ASAP to open up use across all Covid Indications and for use outside of the USA.
The FDA has clearly boxed us into only one indication for covid and therefore will only allow a EUA for that indication only.
Gilead received an open label full approval for all indications because they could manufacture enough of Velkury to spread across all indications. Not that it works because we know that it was just a lucky trial that showed a benefit after multiple trials that were stopped before they would show a failed completed trial. They massaged that approval when the FDA was hoping for anything to help. Maybe someday the FDA will hold them to the fire and make them complete another confirmation trial to justify their unlikely positive results again. We need more than hope. We need drugs that actually work. Like our little miracle Leronlimab.
The FDA has already spoken to that as a reason they would not consider us for Mild to Moderate. Too little product to spread to other indications. So manufacturing is everything and hopefully they are behind the scenes helping by just approving bioreactors at Samsung’s new expansion facility. That would be huge if the FDA could speed the process of manufacturing for Leronlimab by approving more bioreactors at Samsung or possibly AGC too. AGC has their new purchase of a large facility they purchased in Colorado and is needing bioreactor approvals for us and others to ramp it up for production. If that was happening behind the scenes by the FDA or OWS pushing the FDA. We might not be limited in manufacturing. That is our biggest issue going forward and the FDA should be prioritizing it either now before approval or realize that it must be accomplished ASAP to open up use across all Covid Indications and for use outside of the USA.
The FDA has clearly boxed us into only one indication for covid and therefore will only allow a EUA for that indication only.
Gilead received an open label full approval for all indications because they could manufacture enough of Velkury to spread across all indications. Not that it works because we know that it was just a lucky trial that showed a benefit after multiple trials that were stopped before they would show a failed completed trial. They massaged that approval when the FDA was hoping for anything to help. Maybe someday the FDA will hold them to the fire and make them complete another confirmation trial to justify their unlikely positive results again. We need more than hope. We need drugs that actually work. Like our little miracle Leronlimab.
4
