Just listened to a bit of the call and about 26 minutes in there was a question from an analyst regarding any more formal questions from the FDA. Management replied back that there have been no more formal questions since early this year but remain in dialogue with the FDA in terms of 'checking in'. Management feels good about application and amendment.
So, basically just waiting on FDA and nothing has changed in that regard and WMGI is confident just like BMTI was confident when they resubmitted data. Of course there are no guarantees with the FDA and what they decide but my take is an approval with some specific labeling for using and a post approval study. It would not make sense for anything else with all the time and data and requests and the fact that the prior study met its Primary endpoints and received FDA panel recommendation and subsequent data has backed it up even more based on recent disclosures. Hopefully we hear something soon as next Tuesday will have been 90 days from resubmission of data on questions FDA had from back in January.
Gee, Uni, are we still in limbo here ? The Wright management was right to take a long view, and Sam to accept their protracted deal. Given the actual state of affairs in our government and the continuing lawlessness of the market, I am more cynical than ever and I'm getting older.
Hey twelve, great to hear from you. Yes, still in limbo here. I agree with your assessment of the state of our government and lawlessness of the market. Medtronics (maker of Infuse) must have people in high places at the FDA is my thought! It will be our two year anniversary from the FDS advisory panel vote For Augment approval this coming May 12th! For the last 8 years Gem21s has been used in hundreds of thousands of patients with no problems and its basically the same as Augment!
I think the markets will start their correction in the next week or so. I am still waiting PATH's partnership or buyout or dilution announcement to fund their approved FDA migraine patch.
Yahoo does not allow links to be posted anymore but it was May 12th 2011 or so. There was a good article from Medpagetoday on it. The votes were 10-8 in favor with those against being in the academia world and those for being Orthopedic surgeons and other professionals. The study was approved by the FDA yet some on the panel criticized the study go figure!