Under BTA ST-246 doesn't require FDA to be stockpiled by the govt. or used in an emergency.
After Syria I don't see there being a huge smallpox scare although some wedding crashers in Yemen may have been a tad ticked when the drones beat them to the buffet. Who's to say what they'll go home and concoct.
"col" I would look for late spring, but they could approve at anytime. They already have enough info to make it happen and no reason to not. If you listen to the last quarter call they give info on that point.
FDA has for many decades acknowledged that there is a need for flexibility in applying its standard for approval. For example, one of FDA’s regulations states that: “FDA will approve an application after it determines that the drug meets the statutory standards for safety and effectiveness… While the statutory standards apply to all drugs, the many kinds of drugs that are subject to the statutory standards and the wide range of uses for those drugs demand flexibility in applying the standards. Thus FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards.” 21 C.F.R. § 314.105(c).
FDA publicly has expressed sensitivity to applying this flexibility to new therapies for rare disorders. For example, in his testimony to the United States Senate on June 23, 2010, Dr. Jesse Goodman, FDA Chief Scientist and Deputy Commissioner for Science and Public Health, testifying on “FDA’s Efforts on Rare and Neglected Diseases,” said: “FDA is fully committed to applying the requisite flexibility in the development and review of products for rare diseases, while fulfilling its important responsibility to assure that the products are safe and effective for these highly vulnerable populations. There are numerous examples of drugs approved for treating rare diseases where FDA’s flexibility and sensitivity to the obstacles of drug development for rare diseases has brought forth a successful treatment. Many of the 357 approved orphan drugs have been successfully tested on extremely limited numbers of patients, serving as a testament to FDA’s commitment to these patients. This is possible when the best science is flexibly applied and when therapies are truly effective.”
Spectrollmicro.... You are totally clueless aren't you on the FDA approval process? Truly one of the dumbest and mot blantant inaccurate posts I've ever read. Seriously. You can't get approval without first getting an agreed upon trial protocol agreement with the FDA called a SPA. Siga hasn't even gotten that far. In fact, I doubt if they're even past very preliminary discussions with the FDA on a SPA for ST-246. Why do people like you lie on a message board? Or are you just simply stupid? Which one is it?
Orphan drug is the classification of the market for which the drug addresses. Small potential markets are classified as "Orphan Drugs". "Fast track" is the procedure to expediiteFDA approval of a drug, Apples and