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Posted On: 10/01/2020 2:20:16 AM
Post# of 148908
I see the logic for the initial EUA being S/C. That makes sense given the risk profile (in the fda's eyes) of approving a drug for a very large population. S/C is a safe risk profile for them.
The money is really in the Moderates. ie. you go to work, you get the virus - you go to the doctor , get a needle , go home. The question is - how to tap that market asap because a) I personally want to just go to doctor, get a needle go home so me and my family are safe b) its the big market - if in doubt, take this needle and just go on with your life.
Strategically, we are going to need to Moderate's (I am not thinking milds yet) data.
Once we have supply good etc, and have shown good results with S/C you want to go for the Moderates, and you want the data ready to show why. True you don't worry about the EUA now... but you want it there later so it's ready to pull the trigger on and have the data the fda needs. Time is your enemy with these trials. Starting now gives you high N in trials, which a) shows it works b) at a high enough number statistically that it can be trusted.
The issue we have today is we have the hint it works (yes a very good one) , but the numbers are not sufficient to give organizations like the FDA the warm inner glow that this is working in a way that they can't be be blamed for things later. My own gut feeling is they are okay defending an S/C decision as the reward out ways the risks for that population.
If you get the BLA for HIV, it also makes it easy to add to the label as again - you have the data ready to go. You get insurance paying for it etc.
Just how I am looking at. I could be wrong. Your milage may very.
The money is really in the Moderates. ie. you go to work, you get the virus - you go to the doctor , get a needle , go home. The question is - how to tap that market asap because a) I personally want to just go to doctor, get a needle go home so me and my family are safe b) its the big market - if in doubt, take this needle and just go on with your life.
Strategically, we are going to need to Moderate's (I am not thinking milds yet) data.
Once we have supply good etc, and have shown good results with S/C you want to go for the Moderates, and you want the data ready to show why. True you don't worry about the EUA now... but you want it there later so it's ready to pull the trigger on and have the data the fda needs. Time is your enemy with these trials. Starting now gives you high N in trials, which a) shows it works b) at a high enough number statistically that it can be trusted.
The issue we have today is we have the hint it works (yes a very good one) , but the numbers are not sufficient to give organizations like the FDA the warm inner glow that this is working in a way that they can't be be blamed for things later. My own gut feeling is they are okay defending an S/C decision as the reward out ways the risks for that population.
If you get the BLA for HIV, it also makes it easy to add to the label as again - you have the data ready to go. You get insurance paying for it etc.
Just how I am looking at. I could be wrong. Your milage may very.
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