I agree with you , dealing with those most difficu
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Posted On: 10/13/2019 4:38:57 AM
Re: Evil Rabbit #9513
I agree with you , dealing with those most difficult patients with resistance , and having medicine without any serious side effect it is really terrible not to be approved yet .,
I hope that after BLA will be accepted by them no later then November , they can look at stability of 700 mg , as they reviewing second and third part ,
they will approve sooner that in 6 months after that ...
They already know this drug so well ...and they delayed for long enough !!!
Enough of this playing around ......
If they will not add in the last minute 10 more patients to our study , and approve 81% efficacy with 350 mg , we could be approved about 10 -12 months ago ..,
IMO as always .
I hope that after BLA will be accepted by them no later then November , they can look at stability of 700 mg , as they reviewing second and third part ,
they will approve sooner that in 6 months after that ...
They already know this drug so well ...and they delayed for long enough !!!
Enough of this playing around ......
If they will not add in the last minute 10 more patients to our study , and approve 81% efficacy with 350 mg , we could be approved about 10 -12 months ago ..,
IMO as always .
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