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Thread: Now we are waiting for the FDA to approve the drug.

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    Administrator FavStocks has disabled reputation FavStocks's Avatar
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    Post Now we are waiting for the FDA to approve the drug.

    So you know the biotech market is hot right now especially after VNDA’s 900% gain overnight. People are now trying to find the next hidden gem biotech stock that will multiply your investment.

    In the biotech world, FDA decisions can be a gamble but statistics are on your side. 70%-90% of all drugs in Phase 3 testing receive FDA approval. The reason why so many drugs are approved at that point is because most the unsuccessful ones are weeded out in the Phase 1, 2, and 3 trials.

    To help you find the next big biotech stock waiting for FDA approval, we are for a limited time giving away a FREE FDA Calendar to the next 1,000 new forum members of the FavStock.com stock forums.

    Don’t worry the forum is completely free and the FREE FDA Calendar is actually free, that mean no credit card, no fine print, no games, no BS. This is on a first come first serve biases. Stop by FavStocks.com and get your FREE FDA Calendar now!

    http://www.favstocks.com/forum/fda-calendar/

    http://www.favstocks.com/forum/



    If you’re interested in the following stocks your probably interested in the calendar;
    Nephros, Inc. (OTC:NEPH)
    BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
    Amgen, Inc. (NASDAQ:AMGN)
    Gilead Sciences, Inc. (NASDAQ:GILD)
    Celgene Corporation (NASDAQ:CELG)
    Geron Corporation (NASDAQ:GERN)

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    Last edited by FavStocks; 07-10-2009 at 07:40 PM.

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    Junior Member stktr8dr is on a distinguished road
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    Default FDA lagging in PDUFA

    I have been following the biomed selection of stocks for approximately 3 months. It has been my experience that the FDA is not currently meeting their PDUFA approval decisions according to their projected calendar dates.

    Most credible sources attribute the lag to insufficient staffing levels at that FDA. What percentage of "on time" decisions do you believe the FDA has been making in 2009?

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    Member Canada is a splendid one to behold Canada is a splendid one to behold Canada is a splendid one to behold Canada is a splendid one to behold Canada is a splendid one to behold Canada is a splendid one to behold Canada's Avatar
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    Quote Originally Posted by stktr8dr View Post
    I have been following the biomed selection of stocks for approximately 3 months. It has been my experience that the FDA is not currently meeting their PDUFA approval decisions according to their projected calendar dates.

    Most credible sources attribute the lag to insufficient staffing levels at that FDA. What percentage of "on time" decisions do you believe the FDA has been making in 2009?
    I could not give you what percentage of "on time" decisions FDA delivered, but 90% of the time they failed to make decision on time in this year (may be I am little week in math )

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    Junior Member stktr8dr is on a distinguished road
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    Default Good news for FDA

    Federal funding for the FDA is scheduled to rise to 2.35 billion in FY2010, 298.6 million above FY2009. The money will contain 3 critical components for FDA:
    1. 134million for the foods center and field activities
    2. 44 million for the drugs center and field activities
    3. 35 million for the medical devices center and field activities

    With these increases, FDA will hire additional inspectors and conduct more domestic and foreign food and medical products inspections.

    The increased staff for inspections and other internal processes within the FDA will hopefully assure the approvals will be completed in a more timely manner. Great news (IMO) for us as investors.

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    Junior Member reachkantish is on a distinguished road
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    I invested in INSV after FDA approval. But, it is going only downhill since. No one seems to be interested in it.

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    Junior Member kingAndI is on a distinguished road
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    Quote Originally Posted by stktr8dr View Post
    I have been following the biomed selection of stocks for approximately 3 months. It has been my experience that the FDA is not currently meeting their PDUFA approval decisions according to their projected calendar dates.

    Most credible sources attribute the lag to insufficient staffing levels at that FDA. What percentage of "on time" decisions do you believe the FDA has been making in 2009?

  7. #7
    Junior Member kingAndI is on a distinguished road
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    Quote Originally Posted by reachkantish View Post
    I invested in INSV after FDA approval. But, it is going only downhill since. No one seems to be interested in it.
    I invested in anpi a month ago and now it droped like a rock.

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    Junior Member aravind is on a distinguished road
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    Lightbulb Insv

    You should have invested immediately after the FDA approval for INSV.

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    Junior Member mtlmoody is on a distinguished road
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    Most of the times, lagging FDA approval also have adverse effect on s.p. I think NRI might get it on time as thisis their third attempt with few requirements only..

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    Junior Member fdastock is on a distinguished road
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    Smile

    Quote Originally Posted by stktr8dr View Post
    Federal funding for the FDA is scheduled to rise to 2.35 billion in FY2010, 298.6 million above FY2009. The money will contain 3 critical components for FDA:
    1. 134million for the foods center and field activities
    2. 44 million for the drugs center and field activities
    3. 35 million for the medical devices center and field activities

    With these increases, FDA will hire additional inspectors and conduct more domestic and foreign food and medical products inspections.

    The increased staff for inspections and other internal processes within the FDA will hopefully assure the approvals will be completed in a more timely manner. Great news (IMO) for us as investors.
    are you sure?

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