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Affymax, Inc. (AFFY) Message Board

  • godwinpeak godwinpeak Aug 20, 2013 1:43 PM Flag

    Ever Wonder Why AFFY Warns O Investigation May Be Lengthy?

    While FDA regs say most recalls should be resolved in 3 months time, it has been about 6 months since O's late Feb 2013 recall. Think it could take 6 months more or longer before Takeda convinces the FDA approve O's return? Here are some of the forms AFFY/Takeda were required to complete as part of O's voluntary recall:
    Attachment D - Health Hazard Evaluation Worksheet
    1. PRODUCT/IDENTIFICATION NUMBER/USAGE (e.g. unit, lot, serial number, catalogue number, order number, etc.)
    4. (a) Have any adverse reaction reports or other indication of injuries or diseases been reported relating to this problem?
    [ ] No
    [ ] Yes - Attach copies or explain
    (b) Have any adverse reaction reports or other indication of injuries or diseases been reported for similar situations?
    [ ] No
    [ ] Yes - Attach copies or explain
    (c) Is the problem easily identified by the user?
    [ ] No
    [ ] Yes
    5. What is the risk to the general population?
    (a) For products not bearing dosage information, what is the normal consumption of the product by the general population and the population most at risk.
    6. What segment(s) of the population is most at risk and why?
    [e.g. entire population(animals/species), infants, children, elderly, pregnant women, women of child bearing age, nursing mothers, surgical patients, immune suppressed, clinical situations, food producing animals, non-food producing animals, other].
    (a) Is there any known/accepted off labeled use(s) that would increase or change the population at risk.
    7. Within the population at risk, could individuals suffering from any particular conditions or diseases be more or less at risk and if so, why?
    [e.g. Immune system debilities, diabetes, cardiac problem, concomitant medications, etc.]

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Let me get my 2 cents on this . With my food industry background, I have been a part of few recalls myself here in Canada.
      Broadly speaking a recall comprises of:
      1) problem identification
      2) product/quantity and lot identified
      3) product taken in control
      4) root cause analysis
      5) preventative measures and validation
      6) record keeping

      FDA is responsible for going through the above at the end of the process as part of verification. Takes is responsible for doing the above task

      Typically in food/ drug recalls until the root cause points toward the inherent safety of the product or lack of company's intention to resolve issues, products are not banned or licence revoked. The idea is to bring back to compliance. FDA shall not suggest anything abt this. All that they'll do is to review Takedas assessment and if they are satisfied, they'll give the green signal. Also there is no set time period for a recall. Its upto Takeda however long they take.

      Sentiment: Hold

    • Keep talking as the stock goes up a little more. What is your problem with this situation? 7000, 9000, 10,000, and 20,000 trades too. Earlier was 44,500 in one trade? What you say grrrringo, we cant hear you.

      Be gone please.

      Sentiment: Strong Buy

      • 1 Reply to sayedbiotech
      • sayed. Unless any bad news is released, I have posted that I believe AFFY is going to $2 per share so the Oct 19 calls can be filled. I just hope you and the other longs will be wise enough to take your profits should that scenario play out as I expect it will. IMHO AFFY is not going to ever recover to the pie in the sky share price/valuations that Maxdad and Exp extol. It will go AFFYQ instead.

    • 8. What is the hazard associated with use of the product? Explain and cite literature references when applicable.
      ____ Life-Threatening (death has or could occur)
      ____ Results in permanent impairment of a body function or permanent damage to a body structure
      ____ Necessitates medical or surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function
      ____Temporary or reversible (without medical intervention)
      ____ Limited (transient, minor impairment or complaints)
      ____ No adverse Health Consequences
      ____ Hazard cannot be assessed with the data currently available
      9. What is the probability of an adverse event occurring?
      ____ Every Time _____ Reasonable Probability ____ Remote
      ____ Unlikely ____ Unknown
      Signature Date

      [Form continued in next reply]

      • 2 Replies to godwinpeak
      • I want to apply these questions to Intuitive Surgical at this very time !!!!!!!!

        Is the da Vinci surgical device system killing or causing harm to its patents? Anyone?

        Sentiment: Strong Buy

      • Interestingly, the FDA also requires and considers a market assessment in connection with O's recall. Wonder if the industry standard anemia medications, Epogen/Aranesp, with equivalent efficacy and many years of proven safety profiles, could affect the FDA's decisionmaking about O?

        Recall Product: ______________________________
        Note: This market assessment is to be done by the Center’s medical staff when requested to do so by the Center Recall Coordinator. This assessment should not impact on the health hazard. This assessment will only be used to alert agency personnel to potential drug shortage situations.
        Would removal of this product(s) cause a major disruption relative to the treatment/prevention of disease? ____ No ____ Yes* ____ Not Applicable
        * Please identify any alternative treatments/procedures that are available.


        Center Recall Unit Assessment of Recall
        Conclusion: the degree of seriousness of the hazard [real or potential] to the population at risk?
        [ ] The product is violative and there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. (Class I)
        [ ] The product is violative and use of or exposure to the product
        may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences (life threatening/death) is remote. (Class II)
        [ ] The product is violative and use of or exposure to the product is not likely to cause any adverse health consequences. (Class III)
        [ ] The product involves a minor violation or no violations. (Market Withdrawal)
        Signature(s): Date:

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