[82lsju]

https://www.statnews.com/2020/05/01/fda-...d-19-drug/

Remdesivir gets emergency FDA approval. May affect US trials since itll be hard to recruit a control group now. Gilead execs must be very happy though. Hopefully the stuff works. Does seem more likely to be helpful and less likely to be harmful than plaquenil which already got FDA emergency approval for covid, seemingly based purely on POTUS influence.

here's the FDA fact sheet

https://www.fda.gov/media/137565/download

---

From an interview with Gilead’s CEO
 

• the time to make the drug is now ~6 months (down from ~12 months)
  
• they expect to have ~200,000 treatment courses available by July (~50,000 now and ~140,000 being made) and “millions” of treatment courses available by the end of the year
  

 

How much are you going to be able to manufacture? How much are you to be able to ramp up supply?


I’m very proud of what the team has done since we became aware of this virus in January, both from a clinical perspective, but equally from a manufacturing perspective. So you know, we had around 5,000 treatment courses in January. Today we have more than 50,000 treatment courses, and that number is going to go up, as I said, 140,000 treatment courses plus between now and July. And then we could ramp up, to the end of the year to multiple millions of treatment courses.

Now, the reason that I’m proud of the team is because this is a complicated chemical process. It’s many, many steps. Initially, in January, it took around 12 months from end-to-end to produce this product. Now, based upon the efforts of the team, really fine-tuning all the manufacturing processes, we have that down to now around six months. And immediately in January, when we knew there was even a possibility this medicine could be effective, long before we had any idea, even before the in vitro data came through, we made the commitment as a company to say, this is too important. We have to make every investment that we can in the event that this works given the human need and the societal need here. So we started ordering new raw materials immediately in January. 

What gets us to the 1.5 million donation of vials is that we had a certain amount of raw materials in the supply chain and we were able to order some immediately to get us to the first half of this year. But what allows us to go to an exponential growth in the second half of the year is the actions we took in January to make sure we ordered those long lead-time raw materials, which are just coming in now and six months from now we’ll have end products. So that’s why when you get into the October timeframe, the November timeframe to the December timeframe, you get this very large increase in supply.

 
https://www.statnews.com/2020/04/29/gile...emdesivir/

[82lsju]

https://www.statnews.com/2020/05/01/fda-...d-19-drug/

Remdesivir gets emergency FDA approval. May affect US trials since itll be hard to recruit a control group now. Gilead execs must be very happy though. Hopefully the stuff works. Does seem more likely to be helpful and less likely to be harmful than plaquenil which already got FDA emergency approval for covid, seemingly based purely on POTUS influence.

here's the FDA fact sheet

https://www.fda.gov/media/137565/download

---

From an interview with Gilead’s CEO
 

• the time to make the drug is now ~6 months (down from ~12 months)
  
• they expect to have ~200,000 treatment courses available by July (~50,000 now and ~140,000 being made) and “millions” of treatment courses available by the end of the year
  

 

How much are you going to be able to manufacture? How much are you to be able to ramp up supply?


I’m very proud of what the team has done since we became aware of this virus in January, both from a clinical perspective, but equally from a manufacturing perspective. So you know, we had around 5,000 treatment courses in January. Today we have more than 50,000 treatment courses, and that number is going to go up, as I said, 140,000 treatment courses plus between now and July. And then we could ramp up, to the end of the year to multiple millions of treatment courses.

Now, the reason that I’m proud of the team is because this is a complicated chemical process. It’s many, many steps. Initially, in January, it took around 12 months from end-to-end to produce this product. Now, based upon the efforts of the team, really fine-tuning all the manufacturing processes, we have that down to now around six months. And immediately in January, when we knew there was even a possibility this medicine could be effective, long before we had any idea, even before the in vitro data came through, we made the commitment as a company to say, this is too important. We have to make every investment that we can in the event that this works given the human need and the societal need here. So we started ordering new raw materials immediately in January. 

What gets us to the 1.5 million donation of vials is that we had a certain amount of raw materials in the supply chain and we were able to order some immediately to get us to the first half of this year. But what allows us to go to an exponential growth in the second half of the year is the actions we took in January to make sure we ordered those long lead-time raw materials, which are just coming in now and six months from now we’ll have end products. So that’s why when you get into the October timeframe, the November timeframe to the December timeframe, you get this very large increase in supply.

 
https://www.statnews.com/2020/04/29/gile...emdesivir/