Agreed. It hit me this morning that no government agency would bring people in and then make a major surprise announcement (like breakthrough therapy designation as some of us had hoped). The FDA is seriously considering approving eteplirsen and the commissioner wanted to speak in person to leaders of the DMD community to see what they really think about the drug. This was still a very positive development.
As Dr Temple said in his presentation on AA-it's a team effort to get these drugs to those who need it and do so in a safe manner. In other words, the FDA tells them what's needed (in detail) and it's up to SRPT to provide necessary data. It's not a guessing game. Children's lives are at stake and anyone with any sense knows that.
Prosci I think your statement is not completely true. 1) FDA is allowed to listen on specific drugs. 2) FDA is probably allowed to comment on non Confidential information. 3) If a company waived Confidentiality on some portion of information (unlikely) FDA could go much further in discussion.
4) The FDA could answer a question such as, "Hypothetically, if a company had a trial of 12 patiients on a drug where there were about 2,000 treatable patients in the US and there were no safety issues and proof of surrogate endpoint and some proof of clinical efficacy would that be adequate for AA?" The answer from the FDA would not be "YES" or "NO." It might be more like "Quite Possibly" or in the rarest it might be "Probably impossibly!"