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ImmunoCellular Therapeutics, Ltd. Message Board

  • dkwsj Feb 23, 2013 11:40 PM Flag

    A Question on PDUFA Date for IMUC

    SInce the phase 2 result is expected in December 2013, when could we expect to see it on the FDA calender? Thanks

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    • The issue with reasonable people isn't that the vaccine couldn't likely be approved after P2. It is that it if it works nearly as well as it did in P1, there is no way that we will have 64 deaths by December of this year. There are only about 41 placebo+SOC patients.

      • 3 Replies to discoduck33
      • This is a good discussion! I started investing in IMUC and IMUC CALLs after three highly respected MD PHDs told me that ICT-107 was revolutionary..... This was about 8 months ago..... I have been following the progress for the last 2 years..... A couple comments: It would seems that orphan drug approval and compassionate use would be awarded with a 6 plus month OS advantage along with a P3 Study. The P3 may not be a randomized/placebo, if the data demonstrates 12 plus month increas in OS PFS. Also this Particular DC Therapy all the ICTs could apply to 80% of cancers..... the non-clinical OS for Standard of care for GBM is still around 11-13 months.....I understand that the SOC OS will likely be 17 to 19 for this study.....I do not see any reason to use RT and TMZ in future care....apply the ICTs as quickly after surgery as possible to avoid massive up regulation of growth hormones during the post surgery healing process....the ICTs will also likely to be combined with immuno-stimulants and other adjuncts

        Sentiment: Strong Buy

      • Doesnt anyone listen to the CCs? At the last presentation it was CLEARLY stated by mangement that they expected 32 deaths in the 1st QTR 2013! So waht is all this foolishness about not reaching 32 mark until 2014?

      • If the vaccine works the same way as phase 1 or better due to more and stronger vaccines this time next year we'll still be sending messages back and forth waiting for the 64 events. I am already speculating about that and what impact this will have on the share price. Right now IMUC has enough cash but once you get into 2014 they need to finance the other trials, daily opex etc. We would know by then that the vaccine works so I am thinking that raising money at a better price should not be an issue but who knows what general market sentiment would be this time next year. Also, if the vaccine works that great it should hopefully be reflected in the interim results which then would not happen till late summer. At that point it is a question mark if the FDA would like the trial to continue or not.

    • Is this a serious question? lol After phase II, company meets with FDA to determine if phase III is needed. If phase III trials are needed, we could be years away from an NDA filing.

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