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Galena Biopharma, Inc. Message Board

  • bodyshopguyla bodyshopguyla Apr 17, 2013 5:22 PM Flag

    relistically, when could this get approved and be on the market?

    holding 3k shares

    Sentiment: Buy

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    • check the Seeking Alpha article on the summary page.The article states we could see something in 2014

      Sentiment: Buy

    • If we follow FDA's steps, it is 36 months from the beginning of Phase 3 clinical trial which may have started at the beginning of 2013. Up to now, we do not know for sure the offical start date of Phase 3. Assuming that everything moves smoothly, it should be 3 years from the official start date.

      Note that there are Phase 3 interim reports. If the interim reports show overwhelming positive results, the FDA may grant NeuVax a fast track status which can cut the 36 months into aboyt 18 months.

      I think that the company would prepare NeuVax for marketing if it know how positive those results will turn out.
      It takes time to gear up production and it also takes time to market the approves NeuVax to oncological centre.

      Having said all these, once the FDA approvals, it will shoot up Gale's share price by several hundred percentage points.

      If you have the patience and wait, fine. You will be nicely rewarded.

      I look at this as an investment stock. I have been buying and holding for more than a year. I will continue to accumulate and hold for the next 2 years.

      Gale is not a speculative stock. Nor is it a day-trading stock.

      Happy investing!

      Very strong Buy of Gale shares and hold!!!

    • The turtle will win this race.... if you're looking for $15 next week its not happening, but $3 is always possible.

      • 1 Reply to peteg626
      • 888

        Your numbers are inaccurate

        Gale trial will take 3 yrs Minimum. Then another 6 months at least to collate data and submit and application to the FDA. Then they will give a PDUFA date which will be another 6/9 months minimum. Unless FDA decides to fast track things one is looking at 4/5 years from here to approval

        Company has to prepare samples for the FDA approval. They hv to get the commercial manufacturing facilities inspected/approved by the FDA. These things take time. But a company can do some of These during the approval process

        If approved, mktg NeuVax won't problem. Patients/oncologists will find it

        There is no guarantee a 3/4 trial will be successful

        FDA approval is unpredictable for any product unless the trial results are stellar in efficacy and safety

        Stocks are there for investing So stocks are investment stocks

        GALE is vey much a speculative stock as a lot is depending on a 4 year trial and FDA approval

        It also looks like a day trading stock judging from the retail volume.

    • thats a ways away from today, but short term catalysts to potentially raise gale pps are corp update tues morn and presenting at ASCO next month

      • 1 Reply to pkraus12
      • this stock is fighting short sellers worst than most. On a rumor not nearly as fantastic as GALE's real acheivements pphm went to the moon. Every time GALE starts to climb AF puts out a signal. I don't believe in conspiracies but this one is real. I have 50k shares and plan to continue to buy for the next 3 years. 6-17 should be the longest needed. Possibly the results will be available a little earlier. The price should be 5.00 by this fall if good interims come out. It will slowly climb until p-3 is over. Then it will be straight up.

        Sentiment: Strong Buy

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