Post by
cardu on Aug 26, 2015 4:57pm
From the FDA
" Applications are expected to be complete as agreed upon by the FDA and the applicant at the presubmission meeting. Incomplete applications, including applications with minor components not received within 30 calendar days after receipt of the original application, as agreed at the presubmission meeting, will be subject to an RTF decision."
Looks like no RTF for us.
Comment by
loveshackdave on Aug 26, 2015 5:13pm
I don't see anywhere in that document that says this is the only way to receive a RTF decision but, regardless, I think an RTF is unlikely at this point.
Comment by
princeofcut on Aug 26, 2015 5:15pm
cardu, no offense but what you posted doesn't support your statement...comma's mean something except to the TST bagholder cabel who demonstrate with every one of their delusional, paranoid, angry, violent and sexually demented posts that they lack any command of anything except providing me endless entertainment. regards.
Comment by
simouuun on Aug 26, 2015 5:23pm
Cardu.. no. But anyway, we won't get RTF. The only decision IMO now is priority review or standard review. For me, cancer treatmens with unmet medical need alone = PR. And the US investors... who invests such a big number of capital before a (actually) fifty-fifty decision? the us boys must be convinced. the trend is your friend - look - TST accumulated at a partly dreadful market.