Dit is van een zekere Mel van het Y-forum. Hij heeft gelijk: dit is de beste ‘check’ die we hebben:
Welcome to the wonderful world of biotech. The road to approvals is rarely a straight line. Here are my takeaways from this mornings announcement.
The Covid mild/moderate trial data is being unblinded this week. That is great news. They are also doing the safety review of the severe/critical data, which means if the data is good, they will immediately stop the placebo arm of the trial so that those patients can be given Leronlimab too. This is what we've been waiting for. Knowing what we know about the science of this drug, and the improvements patients have been experiencing, this would normally send the stock flying upwards.
The BLA for HIV does not appear to be a major setback at all, on the contrary, they have said no additional trials are necessary. This means it's a procedural issue with the filing that needs correcting. The fact that the FDA is recommending a meeting is very, very good because those meetings are how they walk you through the application to approvals as quickly as possible. Again, people who aren't familiar with biotech may feel unsettled, but this is not bad news. It's fairly common. For example, Gilead, Roche, Genentech all received this same kind of rulings on drugs that were eventually approved.