When we used dose of 350 mg in combo , they used t
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Posted On: 10/01/2019 5:59:06 PM
Re: generactor #9082
When we used dose of 350 mg in combo , they used that in 2 injections of 175 mg each ..
So they have stability of drug for 175 mg...
In mono they started to increase dose above 350 mg , to 525 and 700 mg to get higher efficacy ,
FDA , I don’t know why told them that with 350 they have 81% efficacy in combo , but since they can see higher efficacy in mono with higher dose ,
this what FDA asked them to do with combo , 525 and 700 mg ...without doing another study , but with certain number of patients on 525 and 700 mg for safety..and they accepted them from mono study...
and stability of drug at 2.4 ml also , so about 350 mg ..,..
until now they have stability for 175 mg for about one year.
Should company predict that and do It sooner , possibly ...
But they are few people company with a lot of things on their plate ...
In November /December it should be done ..,
So they have stability of drug for 175 mg...
In mono they started to increase dose above 350 mg , to 525 and 700 mg to get higher efficacy ,
FDA , I don’t know why told them that with 350 they have 81% efficacy in combo , but since they can see higher efficacy in mono with higher dose ,
this what FDA asked them to do with combo , 525 and 700 mg ...without doing another study , but with certain number of patients on 525 and 700 mg for safety..and they accepted them from mono study...
and stability of drug at 2.4 ml also , so about 350 mg ..,..
until now they have stability for 175 mg for about one year.
Should company predict that and do It sooner , possibly ...
But they are few people company with a lot of things on their plate ...
In November /December it should be done ..,
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