I said I had nothing but respect for the FDA process, and no reason to believe there were deliberate attempts by SIGA to delay it. SIGA expects the FDA process to take about 5 years (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3151656/) so there's time to look at alternatives. With respect to these alternatives to ST-246, they already exist in the SIGA patents (as mentioned above) and don't require the screening of 300,000 more compounds. The required steps in the FDA approval process are now well known to SIGA and will be used as other drugs are put into the pipeline. Maybe SIGA just accepts that cyclononenes are the whole future and shares profits 50/50 with PIP. Others would suggest that since you've already invented alternatives, at least let them see the light of day. At any rate, this should be confidential to SIGA until otherwise necessary. If the strategy is promising, great. If not, file the results in the big circular file.
Having gone through the FDA process for chemical approvals, I have no reason to believe that the delays for SIGA are anything but legitimate. FDA has to maintain impeccable standards. However, if SIGA is not secretly pushing a huge research team to identify the best ST-247 (as you put it) that skirts the Parsons ruling, then Merck or Pfizer or Bristol Myers Squibb will be there first with their own version. They've also read the patents and a $2 billion contract makes it interesting for them.
Actually, no. In his May 31 judgment, Parsons rejected Parmathene's ST-246 definition and restricted ST-246 to "the same family of cyclononenes" (cf. page 7). Parsons decided to restrict the scope to what was already in the LATS, but a biochemist would know that the "cyclononene" is not the action part of the drug mechanism: the "indole-amide" is. In the original SIGA patent (US '641) at least 5 other compounds that were not "cyclononenes" but did have "indole-amide" groups tested as effective as ST-246. If I'm SIGA, I put "cyclononenes" on the side-burner and get FDA approval for the other equally effective compounds. The time is worth the $$$. IMO.
i dont really know...that's why i am asking.If the newly discovered form 1 of ST246 is working well why PIP should have rights on this drug?..when the two companies were trying to merge the new form was not in existance...be nice bro,iam just a cook.