The board sounds crazy right now with speculation. I have been involved with discussions between pharma and FDA staff as part of Ph. 3 studies for orphan conditions. Given the company's statements last year about formal revised SAP submission, how very long that process took, and now being followed by announced locking of primary data 6 weeks ago with TLD planned for 2 days ago, there is NO way they are just now trying to amend the SAP with the FDA. At best, all the FDA would have ever said (months ago) would be "here is what our statisticians recommend, you can do what you want but we cannot promise that the committee reviewing your application will agree." The FDA does not tell companies how to analyze data or promise anything - they simply provide feedback on what companies propose if requested. There is no way that the company has not already locked into their statistical approach based on prior FDA feedback. The FDA does not regulate how TLD announcements are made and does not opine on approval issues until a submission is made. So, IF the FDA is somehow responsible for delays in TLD, the only realistic thing it could be is that the company has a formal regulatory application in process. This flies in the face of total lack of any hint from the company that they have formally applied for anything yet. This seems possible but unlikely. The only reason we might suspect the FDA is involved is third hand information from posters who have spoken with DI who is unlikely to be fully in the loop given his role having direct contact with investors. I have doubts about real FDA involvement. Speculation that the company is involved in partnership negotiations are more plausible as a reason for delay of TLD, even though it too is a bit far-fetched. The delay could be for other reasons entirely, and DI could be using the FDA as a convenient bad guy. Maybe the results are not totally straightforward and it is taking more time than expected for them to get all of their ducks in a row before announcement. Bottom line is we really have no clear idea what the delay reason is, and in the absence of any PR saying there is a significant delay even though they have passed their expected deadline, it is most reasonable to assume that an announcement of TLD will be made soon. My guess is next week.
