This is why I still don't understand why in the last minute FDA added 10 more very difficult to find patients , from 40 to 50 for combo , and why they delay now close to a year again with choosing the dose ,
with 350 mg we have 81% efficacy , much better than 45% of Maraviroc and 43 % with Ibalisumab ...
Why not to approve it ????
Then they noticed first that 525 works better. then 350 and 700 mg ...ok , we have data for long time , now they want data from 700 mg ..
There must be a reason they doing everything IMO to delay us ..
And yes , FDA is knowledgeable , serious always APPEARING helpful...
But we know that problems do happen, some biotech is suing them now...
And for a biotech company to be so brave a sue FDA , IMO must be something important , I will try to follow this case...
All IMO as always....
with 350 mg we have 81% efficacy , much better than 45% of Maraviroc and 43 % with Ibalisumab ...
Why not to approve it ????
Then they noticed first that 525 works better. then 350 and 700 mg ...ok , we have data for long time , now they want data from 700 mg ..
There must be a reason they doing everything IMO to delay us ..
And yes , FDA is knowledgeable , serious always APPEARING helpful...
But we know that problems do happen, some biotech is suing them now...
And for a biotech company to be so brave a sue FDA , IMO must be something important , I will try to follow this case...
All IMO as always....