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Athersys, Inc. Message Board

  • barcoconut barcoconut Mar 18, 2013 9:05 PM Flag

    The FDA's new "breakthrough" product designation

    Has Athx applied for this?
    "The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.

    "A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA'sCenter for Drug Evaluation and Research. MARKETWIRE

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    • No Athersys has not applied. If they did try and not succeed that is not a big deal because it did not cost the company much money, just some effort and time.

      For those that express safety for the patients concern, let's see if they still feel the same way if they had a stroke and now paralyzed from the neck down or if they had terminally ill decease and have 2 months max to live. Would you still rather wait another 5-7 years (going through phase 2 and 3 testings) make sure the drug is "safe". There is only one thing safe for sure and that is 5-7 years of paralyzed from the neck down suffering or a dead corpse in other scenario. If you have ever wondered why all those terminally ill patients with plenty of $money in their pockets travel oversea to find some hopeful reliefs, wonder no more.

    • Lol if so its an early payday for us, but thats not safe for patients

      Sentiment: Strong Buy

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