I hope you are not serious. If you really did contact FDA, it was very unwise (and selfish) of you to have done so. Can we just let the company handle this and not do anything more that could offend someone at FDA? Please? Good grief.
Amended PMA was filed in July 2014 under new CEO after meeting with FDA to review responses to questions/concerns articulated in FDA's previous action (their second) not approving the original application. In 3/26/15 cc, CEO said FDA had said the 6 month timetable for response does not apply to an amended PMA, but that action was expected soon.
Below is excerpt (from SA transcript):
Finally, with regard to PMA amendment for LuViva we have been told by the FDA that once a company has received the non-approvable letter which we received in September 2013 the FDA is not held to the same timeline performance standards as an initial filing, they do restart the clock but the 180 days is not a performance goal for the FDA. With that said they have missed several dates they provided to us verbally and in writing primarily due to other priorities including PMAs that were on the clock and nationwide issues that have risen including the UCLA Super Bug which also bumped our PMA amendment in their queue.
We continue to be in contact with our consultants and FDA and have been told that review of our PMA amendment will be completed shortly. We remain hopeful that they will provide us with the path for approval.
Fwiw, I am skeptical that today's action is driven by a leak of FDA approval, but who really knows. Yesterday's PR re additional funding and agreement re marketing in China throws a lifeline. Somebody obviously thinks the chances that the company will survive are better today than before. Great product, just need orders from countries where approved to get company through to FDA approval.