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Pharmacyclics, Inc. Message Board

  • azelfage azelfage Jun 7, 2012 9:45 AM Flag

    NO accelerated approval for PCYC

    there was a lot of pumping going on on the board yesterday RE accelerated approval. the question was raised at the CC and the answer was a clear NO. They are not going for accelerated approval and not expecting it.
    so you all have to wait for PIII to start and finish for your next catalyst. about 4 (four) years if all goes well.
    no more "accelerated approval next year" pumping please.

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    • Let alone hire marketing head from Novartis. For 2020?

      Go back and look at the data used for original gleevec approval. There are many other examples of non pivotal p2 studies driving AA.

      My bet is by the time the first patient starts on all of currently planned P3, we'll have a communication about AA.

    • take us back to phase two? Hey we are moving forward if you don't know. A pivotal phase 3 will be done. Plenty of phase 3's will be going on. Analyst are not going to put their neck out on here say. As soon as the FDA confirms what we all speculate it will be too late for you.

    • lets clarify something why would they hire a person for global manufacturing and technical operations?Just think about it.Also if you are short or sold and wan't back in thats ok to each his own.One thing though it doesn't look like anyone is scared of holding long IMO. Heow Tan, Senior Vice President, Global Manufacturing and Technical Operations
      Heow Tan joined Pharmacyclics in May 2012 as the Senior Vice President, Global Manufacturing and Technical Operations after working for 26 years in the pharmaceutical industry. His experience in CMC included working with oral, semi-solid and parenteral products, and has successfully led the filing of several US NDAs, ANDA and European MAA. In Pharmacyclics, he is responsible for CMC Development, Global Manufacturing and Supply Chain. Prior to Pharmacyclics, Heow worked as Senior Vice President, Technical Operations for both Collegium Pharmaceutical and PreCision Dermatology (a spun off company of Collegium). In both companies, he was responsible for CMC Product Development, Manufacturing and Supply Chain activities. Prior to Collegium and PreCision, he worked at Praecis Pharmaceuticals Inc., Waltham, Massachusetts as Vice President of Industrial Operations and Development; He had also served as the Director of Manufacturing Operations for SciClone Pharmaceuticals Incorporated, San Mateo, California. Heow started his career in the pharmaceutical industry working for Syntex Laboratories in Palo Alto, California, serving as the Manager of Manufacturing Engineering and Manager of Materials Control. He obtained his M.S. in Engineering from the Ohio State University and his MBA from the Santa Clara University, California.

    • lets clarify what we are talking about.
      they can do another PII study in a subgroup and get AA in that as long as FDA agrees with the trial design and unmet need. but that study would be designated "pivotal" from the get go.
      non of the current PII studies are pivotal. they can't file for AA with the data from these current trials.
      so several more years are required for any sort of marketing approval. my guess is at least 4 years from today if all goes well.
      even the most optimistic analyst, you know who, has given 2020 for any kind of significant revenue figure.
      can someone with real insight confirm me please?

    • Get back into 2003 where Pharmacyclics once got a" fast track approval for Xcytrin. Most of the guys here know what happened after.
      This time things are much different, thanks to Bob D. and things are also planned in a different, much more efficient direction now.

      Lets talk back in 12 months from now ..things are going to be very exiting

    • con man are you. I bet you can't put any of your money behind your own words. Let me know if you can and how you plan to do it. NO PUMP JOB ITS JUST COMMON SENSE> something you radicals lack.

    • Are you worried about something? Why do you feel the need of a negative post when all recent news is very positive .We do not have many pumpers and very few bashers .Unless you consider Webush and Bean Murray pumpers.Also the success of ibrutinib speaks for itself.

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