Monday N.Rthe friday meeting was just that, a type A meeting, it is impossible that FDA was going to reverse their decision right on the spot , the meeting was not for FDA to make any decision in fact, it was exactly what it is supposed to be, to provide some clarifications on the full response letters and help guide TST with their pathfoward.
that being said, in their new release on the april 12th, they did set monday following the meeting to issue a new release....that does sound interesting because typically it took FDA 30 or 60 days to provide a formal response to the type A meeting.
what could they issue in the new release? my best guess is the focus of the new release will not be the type A meeting, it is likely something that has been in the cooking for a while, likely to announce a U.S partner with a deep pocket that will help them in the pathfoward? it is understandable whoever this partnership is, they need to see the outcome of the type A meeting as well before making the final commitment, so they have a better idea what they sign up to. the news release will be statement that they are back on track to get the approval under this new partnership.
hopefully it wil gap up to where it was before the full shot down letter came.
welll, we will find out monday morning...everyone just relax and enjoy the ride.
good luck to you all