Hi Misiu, In my opinion if FDA comes back with
Post# of 146092
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Posted On: 10/11/2019 12:44:21 PM
Hi Misiu,
In my opinion if FDA comes back with some new requirement when 2nd part of BLA is supposed to be filed, it would kind of worry me that they are holding it up on purpose. Especially since efficacy is in the 40's on 2 drugs with major side effects already approved. I can understand the FDA coming up and saying, since you want to use this test with your patients to determine how many mg to use, we need data from the 700mg patients as well. Maybe they are going to get all 3 dosages approved, and that is why Nadar said, you will understand when it all happens. This is all in my opinion though, but seems the most logical.
In my opinion if FDA comes back with some new requirement when 2nd part of BLA is supposed to be filed, it would kind of worry me that they are holding it up on purpose. Especially since efficacy is in the 40's on 2 drugs with major side effects already approved. I can understand the FDA coming up and saying, since you want to use this test with your patients to determine how many mg to use, we need data from the 700mg patients as well. Maybe they are going to get all 3 dosages approved, and that is why Nadar said, you will understand when it all happens. This is all in my opinion though, but seems the most logical.
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