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Titan Pharmaceuticals Inc. Message Board

  • sexyladyfitness sexyladyfitness Apr 19, 2013 11:39 AM Flag

    Nowak' Important please reply.Manufacturing/NDA

    As we get close to approval decision, tension rises for shareholders..
    Awhile back you posted here that you was informed that there are no manufacturing issues-
    That gave the perception that someone in management told you something, so can you please elaborate on that? Approval relies on this most important issue.My only skepticism on approval of Probuphine would be the stability studies and IF FDA requested multiple commercial drug batches that Titan did or did not provide them.
    Due to FDA's earlier concern about the efficacy of Probuphine's dosage, the FDA might and I say might' wanted Titan to test multiple batches to confirm drug's stability,not just the one batch originally filed with the NDA.
    We dont know, but maybe Titan did provide them what they needed IF this was requested.
    Manufacturing would be the only reason for a potential CRL but if this is a non issue,then approval will come next week or in 3 months the latest' IF a REMS delay.
    Probuphine is surely more likely than not to get approved, but we must all be aware of any slight possibilities of a different outcome.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Titan's books got audited left to right and top to bottom by some of the best regulatory/manufacturing people and those brilliant people decided to plunk down $20M. That is what that nitty-gritty dance is all about. If proB gets rejected for the CMCs, then we are all just an unlucky bunch. Very few would have seen a rejection coming.

    • Wow Sexy:
      Are you sick or something? Your grammar and sentence structure has suddenly CHANGED DRAMATICALLY in comparison to other of your many posts here. Typos are one thing. Repeated incorrect usage of words "was" rather than "were," multiple mistakes in tense and plurality, together indicates either you're more than one person using a single ID here or are in fact, not our regular poster SEXYLADYFITNESS. In fact, your writing style today actually more closely approximates that of LoveBumper.50cents aka DaveTape/DaveTrape and the cast of myriad 'Joshes.' Since your writing has never been so sloppy, either in style or in its substance, why such a big change? You are in fact, masquerading aren't you?

    • They tested multiple batches and turned them into the FDA...

      I never said someone told me that they are clear on manufacturing. I said I was confident that they are on top of it.

 
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