Thanks for this useful post.
When do you think SRPT will request fast track?
And if all goes well, when wld FDA give (i) approval, and then, (ii) Phase 4 confirmatory approval?
I assume the drug can be sold without Pahse 4 confirmatory approval
Okay - I will check it out, but I am surprised because, the CEO in the Piper Jaffrey presentation says they do not plan any FDA request until they talk with the FDA (in the first quarter) to find out if the drug wld quallify for accelerated approval.
Can you explain?
Also, he says he wld expect a full year test (rather than 6 months) - I assume for the confirmatory study.