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SIGA Technologies Inc. Message Board

  • bernarrdo bernarrdo Mar 5, 2013 7:53 AM Flag

    FDA & shelf life

    I own the stock for several years and I would like someone to help me with two questionsns. Yesterday I read a post on the MB is that ST246 is haven't problems with the dosage and shelf life and that is holding up the shipments. Are we havng a problem with the shelf life? If we are,that is serious.
    I was lead to believe that last year we would file for final FDA approval.Are we still having a problem with the dosage? If not,when can we expect FDA approval soon?
    I would really appreciate hearing from you guys. I am ready to buy more. Bernarrdo

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    • The dosage was settled as part of the labeling concurrence reported last quarter: 600mg/day for 14 days. SIGA received the benchmark payment in 4Q.
      FDA approval IS NOT required for the Strategic National Stockpile. The FDA does not have a set protocol for testing smallpox antivirals so the animal rule is being invoked. Multiple primates are being tested and CEO Rose said there would be no public disclosure of the results. Completion of FDA testing is not expected before delivery of the 2 million doses. FDA approvals are not part of the BARDA requirements.
      Hedges and Amln are right about the chemical stability: ST-246 is a tricyclo carboxamide with a stabilizing trifluoromethyl phenyl substituent. It's not going anywhere.

    • There is no factual basis for the claim that shelf life issues are holding up deliveries to the SNS. This idea was completely fabricated by a PIP investor, and when asked to provide evidence to support his assertion, he could not. If anything, per the contract, Siga will be rewarded if they are able to extend the current shelf life.

      The FDA question has been on my mind as well. We have literally been waiting for years for substantive progress towards an NDA. The remaining hurdles we faced when this was last discussed were the 400+ person trial and a cardiac study. We continue to wait for an update as to what is exactly required to file the NDA. This question should be asked again in the upcoming call. During the Nov. call someone from Noble Financial asked for an update on the studies needed to get to the NDA. Rose said something to this effect: "We have performed multiple experiments already but are still waiting to come to an agreement with the FDA on the final steps. " Could the FDA be stalling for this long...yes. Could the company be stalling as some part of a legal tactic with PIP..who knows?

      Also on my mind, if we're coming up with questions that need answers, is what the GE loan was purposed for. Could they have received direction from the FDA on the final studies and needed a loan to carry them out...who knows?

    • The only problem with shelflife I know of is that the drug is so frigggin stable customers could extend the shelflife by testing, delaying expiry and re-stocking orders, hurting future sales.

 
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