Re: Form 8-K = FDA great News! Not backi
by: tommyvictorisprong 12/09/05 01:56 pm
Msg: 35823 of 35844
Yes, as I have posted before, all we can do is look at the external conduct of those in the know--
9/28 approvable asking for CMC--followed up by strong INSM comments that they have the CMC info readily on hand, and PR 2 weeks later that they provided the info and FDA considers INSM's application complete. Then followed up by INSM statements at conferences that they will be fully commerciallized in 2006. CONCLUSION: FDA asked for a piece to the puzzle, telling INSM the shape and size of the puzzle piece. INSM had the puzzle piece readily on hand and provided it, feeling confident that it had the key to approval to orphan.
TRCA recent lawsuit: CONCLUSION: TRCA strongly suspects or even knows of Iplex approval and orphan. TRCA starting to load its bullets vs. a legit and imminent competitor, legit b/c of approval. Gives TRCA another basis to water down INSM if infringement suit fails: "If we can't stop them from selling through infringement, we'll try to stop them from marketing through deceptive practices suit." Setting up tiers of attack.
Today's 8-K: CONCLUSION: They have time to issue these I believe and didn't have to 8-K it "today." They wouldn't issue this in the face of bad news on FDA decision. Instead, they're issuing this as precursor to major TRCA-INSM war that's going to heat up big time. This is nice show of force before PR on FDA approval, which they may be working on right now as far as we know (i.e. they submitted the 8-K already knowing of approval). In other words, you wouldn't issue 8-K at this time if you thought denial/bad news was coming.
Have a great gut feeling this time around. And, I may get to unload some of my TRCA in the 10's.
By the way, if no news today, you may see a dump into close b/c of fear by some of bad news, many smart investors don't like to hold into news like this, but unfortunately i'm not smart.