Interesting comment below from the minutes of their pre-NDA meeting back in Oct2011. Either Titan mis-read the minutes or something fishy is going on.
"Titan believes that its Phase 3 clinical program completed to date is acceptable to the FDA to support submission of an NDA via the 505(b)(2) pathway and that no additional clinical efficacy or safety studies are required to support the submission."
Sentiment: Strong Buy
FDA could have given this a standard review which would have made this more risky for a CRL.
75% of priority reviews get approved,plus this was under a 505B submission which FDA also could have disallowed if they wanted to.So priority review, 505B submission,stat significant topline clinical data, an advisory committee who voted for approval,this should not have received a CRL.
We are in an environment now where the FDA is loosening up their review process on many drugs in order to get them to market quickly,even with drugs having incomplete safety/efficacy data,yet Probuphine they put up a big roadblock against it's approval-totally unfair.Go figure..
Somebody besides FDA doesnt want Probuphine commercially availabler ight now.
CORRECT Sexy...And that, I believe, is the topic (or perhaps the suggestion) of the TV story on its way as we write. I'd wager RB is in it somewhere since if you recall, their behavior with Suboxone, their film, their whole "website for helping addicts"....that timing was SO VERY curious and their actions were as well. I keep going back to that viability study they abandoned and how it was PRECISELY what Probuphine turned out to be. Yes, there's definitely something mysterious going on and perhaps we'll never know but if the FDA has been caught in corruption yet again, I hope they hang the people they caught, since in essence their greedy behavior has cost human lives and at minimum, GREAT suffering. One has no further to point than yesterday's news on the TN hospital program designed to treat newborns who came into the world addicted to the junk the FDA APPROVED and it has NEVER, not even once, ACCEPTED OR ACKNOWLEDGED the fact that THEY not only put these dangerous drugs on the market but continue to allow them to be marketed, knowing HOW DANGEROUS they are. The FDA is responsible, directly responsible, for the greatest part of this worldwide pandemic. DO THEY REALLY WANT to control this wildfire or NOT? I'm beginning to think where this addiction's concerned, the FDA is saying one thing and doing yet another. The motive for that is less likely incompetence and much more likely criminal...in my opinion. I hope they crucify them if it's true.
The FDA might not have been forthcoming in any meetings as one might think.
That is why I mentioned awhile back that this trial was not under a SPA which under that SPA, pretty much guarantees you know exactly what FDA wants to see out of trial.
The FDA might have been somewhat lackadaisical in communication with Titan without that SPA in place.Just a thought......
Obviously Titan management is inept because they did not understand something within the FDA meetings. Titan management somehow got the impression that everything they submitted was satisfactory for approval - it obviously was not close at all to what the FDA wanted. So someone at Titan has a severe problem understanding communication and that person needs to be fired and replaced by someone from Braeburn. Braeburn needs to take over Titan and clean house - get rid of the uninformed inept dead wood that has just cost this company millions and wiped out millions in shareholder value.
3 months i agree with what your saying, once braeburn gets control all of ttnps management know thier fired even the ones who resigned,, i think they resigned to save public face as to know that the rest will be canned uopn braeburns takeover