It is hard to believe they suspended talk on labeling issues for all this time, and I would think JW would be in a hurry to move this along.
I have a question for Simp and Bionerd which I am hoping you will opine on. I am of the opinion that the FDA is looking for more data as a way to allow Farkas and co. to walk back their public statements and "officially" be in favor of approval, so that if Etep works, they aren't seen as villains who tried to block the "miracle" drugwhen 60 minutes tells the Etep story. I think that the data request on June 6 was an attempt, but wasnt enough, and they are looking for something more. I think the FDA is reaching their limit on how much they can delay this, and I don't think a CRL is in the cards. Does Srpt have enough data now, or will they in the next few weeks, that would be sufficient for Farkas to say he is now on board ( more than they had in June, which doesn't seem to have been sufficient). I am not asking about enough data to really change his mind, just enough so he can point to something new so he can justify a change of position in favor of approval given his adcom comments? Simp or Bionerd, how far fetched is the above scenario? Thanks in advance for any responses.
If she didn't like them, why weren't they changed (or did she have the power to do so)?
Bionerd, is it likely that Farkas took, or is taking the full 35 business days? That just sounds like another way to really #$%$ off the higher ups.
Thanks bionerd. To clarify something, some have said a DPO could only be issued after they cold make the AA section, and that this was dependent on the start of Essence, because that was the only time a decision to go with AA could happen. If that is not the case, is it possible this could be resolved any day now?
Bionerd, what are your thoughts on the DPO timeline? Do you believe it was filed at the same time the IRB approved essence, and if so, do you think it will take the full 35 days ( if for no other reason than to avoid an appeal). Thanks.
So if the FDA had no intention of approving the drug, what is holding up the CRL, particularly given the FDA wanted to give a prompt response, and the fact that DMD kids are holding off on participating in other trials while they await the announcement?
Right now it shows only one site open for recruitment. Does anyone know if there are more currently open? Does the DMD community use this as a resource? Perhaps the FDA wants more sites open before granting they are comfortable granting AA , regardless of the technical definition of "start date".
Are there any major biotech conferences prior to the one srpt asked to participate in? Thanks ( just trying to get a sense of outer boundary)
Mainlylobster, would you please link or refer to the regulations you are talking about? I don't need the exact subsection, but some idea of where to look would be appreciated. Thank you.
Hi. Can you think of any reason why they would have updated over the last two days without changing the date? What possible reason would there be to do it?