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Titan Pharmaceuticals Inc. Message Board

  • cashflow599 cashflow599 Mar 25, 2013 10:55 AM Flag

    TTNP: 3 month delay relating to REMS issue raised @ AdCom?

    More than one investor seems to think that is an issue that will put the April PDUFA on hold.

    I agree.

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    • Nope- an actual delay due to REMS never raised by the FDA at AdCom.
      FDA never said there will be a delay or might be a delay, all they said was its cutting it close on a REMS agreement due to PDUFA coming up soon.They never said they didnt think it can get done in time.
      Priority review designation might' help to get FDA to expedite on this with Braeburn.
      Yes its cutting it close but not out of the question that PDUFA will be on time.
      Yes there is a chance for PDUFA delay and as a few here mentioned,,I doubt it would take 3 additional.months to come to an agreement...
      IF there is a delay, look out for a PR 1 to 2 weeks before PDUFA.

    • Just a 3 month delay for REMs might be read as a positive as it would signal a likely approval after getting it sorted out. It will take Braeburn months to set up and train the sales force and set up the seminars for training the docs. I don't see the 3 month thing as some kind of huge binary event of any significance. The stock is valued quite low right now so clearly a number of shocks and disappointments are already factored in. The REMs thing is pretty much a non-issue to the share price, I think because it has been right out there in the open for neverybody to see. Good luck!

      Sentiment: Strong Buy

    • regardless of delay, i think ultimately there is a approval here. FDA + adcom acknowledged a need for this product. im in, and im in for the win, delay or no delay

    • still time*

    • It took the FDA 1 month and 22 days to validate the first set of REMS.

      We submitted a new one last monday, so that left use with 1 month and 14 days to validate the new submission. If it is exactly like the one the FDA suggested, or if it is close, then we should be ok.

      Like the FDA said, there is still, but we are running out of it. Any delay won't be 3 months.

 
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