Bionerd, what additional information do they still need on detection and quantification?
This has been troubling me for a while. I never expected the FDA to announce that they accepted dystrophin as a surrogate, but after 2 eop2 meetings with a white paper in between, what more can the company provide them on using dystrophin as a surrogate end point? You say this is a reasonable request, but it sounds to me like they have decided to approve etep on the basis of clinical end points, and deal with the surrogate issue once they have more P3 data. I would love to learn I am wrong on this, and ultimately I don't think it will make a difference in terms of approval timing. I just don't understand what more information the FDA can expect to get. Thanks for any response from you or any of the other knowledgeable posters here.
I really think Mr. Gary hit the nail on the head earlier. FDA recognizes and accepts that Etep is a miracle drug, but they want to understand and have hard data on the mechanism that produces this profound efficacy.