The above is an extract from an *endpoints" article. It shows some of the problems the FDA has with accelerated approvals, which is the pathway PTX hopes to follow.
Some of this has been addressed in changes to the process which occurred after the drug from the article received its approval. SYC sometimes refers to the changes in announcements.
Notice how mention is made of how having biomarker evidence can be important. Having evidence of the mode of action of the drug gives the FDA more confidence that any resulting benefit showing in the trial is from the drug.
The above is an extract from an *endpoints" article. It shows...
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