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Geron Corporation (GERN) Message Board

  • lws2000 lws2000 May 9, 2014 4:50 PM Flag

    Mayo's endorsement, patients' immmediate need, good balance sheet, big pharma interest, miracle drug

    What else is needed besides a "green flag" from the FDA?

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    • I just look at the information that comes from Mayo and weigh the positives against the negatives. There are no important negative's in the progress of Imetelstat on the medical side. The market's are rigged, but the medical positives from Mayo will dominate the market negatives eventually.

    • lws: why is it that you and a number of other board members just don't get it?

      The FDA "flagged" Imetelstat over liver damage concerns and GERN did NOT have the data to satisfy those FDA's concerns.

      Until GERN or Mayo presents satisfying data to the FDA, NOTHING WILL CHANGE!!!!


      So, stop the BS and take a drink of REALITY!!!

      Of course, IMO.

      • 4 Replies to blackmarango
      • You really don't know what they have presented to the FDA do you think that the FDA is going to lift a hold with out at least making a pretense that there was a reason for it after destroying 500 million in shareholder value

      • u dont get it either---the lfts are a smokescreen----not dangerous,minimally elevated......and less than from other approved drugs........political in my view.....

        Sentiment: Strong Buy

      • Your "VOID" is rapidly being filled. Mayo and Geron are supplying or have supplied the "MISSING" information to the FDA. I believe that the FDA now has all of the information that they need, and has the hold-release-documents nearing a final draft. Then there will be a careful review before release. The process is slow, but efficient. Time is on our side. Please relax.

        "Geron And The Mayo Clinic Working In Parallel To Release Clinical Hold Of Imetelstat"----(Seeking Alpha, May 2).

      • blackmarango,
        I can agree with your summary as far as it goes, but it certainly leaves out much that is relevant

        If you are implying that the FDA will not likely be satisfied with GERNs data when it is submitted, I think you are probably wrong.

        If you are trying to frame the issue to suggest that the FDA has seen the data and they are turning GERN down on what they have seen so far, I think that is probably wrong.

        If you are trying to imply that the FDA will look at the ET/MM issues the same way it looks at the MF/AML/MDA issues, I think that is probably wrong.

        If you are implying that the FDA "flagged" Imetelstat in the sense that the so-called "flag" applies to the MF/AML/MDA trials, I think that is probably partly wrong.

        If you are implying that "NOTHING WILL CHANGE" because GERN cannot obtain data satisfying to the FDA, I think that is probably wrong.

        When you imply that your simple analysis is the whole story "PERIOD!!!, I think that is most definitely is completely wrong!!!

        While I can agree that your post is essentially correct, yet I find it to be very misleading.

        We all know there is a clinical hold, but the question than everyone wants answered is whether the hold will be lifted and when.

        Your summary is fine as far as it goes, but it does not answer either of the questions.

        You should also stop the BS and pay attention to the real issues that will determine Imetelstat's fate

    • I would be dumbfounded if there weren't at least a couple of majors giving Geron the hairy eyeball and figuring out how much they would have to pay to buy it out. It may well be that they are waiting for the 28th in order to not muddy the water. But, if this isn't the best opportunity to pick it up for cheap, I can't imagine what would be better.

    • Patients' immediate need is the most overwhelming argument. The safety appears proven (over 3 years, including liver) and the effectiveness has been shown in the Mayo studies. Remissions are unique to Imetelstat with potential cures. I would not be surprised by an FDA positive statement by the end of May (perhaps next week) since nobody has presented any negative information (does not exist) concerning Imetelstat. The dosing considerations are well understood now.

      This is the same story over and over again. A great medicine with minimal side-effects trumps all other considerations. Mayo, Geron and the FDA are on the same page (benefit to the cancer patients). May 15 (Merrill, Bank of America Health conference) is the next date of interest.

      • 1 Reply to lws2000
      • 1. For disclosure reasons, GERN will provide status of progress of data collecting efforts.
        2. For face saving reasons, GERN & MAYO will provide FDA with a lot of data of BASELINE Liver Function test data of MF patients. They will show such patients are "NO WORSE OFF" as far as LFT goes.
        3. Again for face saving reasons, FDA will require all future tests of Imetelstat to have a much stronger warning label than the usual standard one for patients entering drug trials. Maybe similar to the labels used in Hepatitis drugs or like the ones for several FDA approved and strong arthritis drugs.

        Sentiment: Strong Buy

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