if taken at their word. watson (wilkinson) mentions "still a few avenues to move forward it is unlikely we pursue those avenues at this time"?? why would watson move forward at this time IF they are going to "go forward" into a new trial with the next gen product they have yet to perfect??? love to hear thoughts? tia onlyfacts? strtjunky? topro? anyone else?
If WPI could not get approval and a P4 from the FDA for prochieve, it makes perfect business sense to go with a new trial using the next gen product. My understanding is they can use the new trial results in conjunction with the previous study results, to show efficacy and meet FDA's two study requirement. They can likely get a patent on the next gen also. My question is: Where is next gen in its development path?
makes sense and allowed watson the time to go thru this lengthy appeal knowing full well if a new trial was needed they would go ahead on the nextgen..i have zero clue and i doubt we get info on next gen developmental stage..above my pay grade..lol
The others you mention are more tuned in than me but I took the "unlikely we pursue" as referring to Prochieve not progesterone products in general. Otherwise I don't see how it can be reconciled with "It is challenging, but nevertheless we’re still committed to the opportunity because we think we can be one of the major players in these types of therapeutic categories" (I did not listen to the entire WPI call and did not hear the latter quote - definitely from today's call, correct?).
I'm sure they were hoping to extend patents for the biogel P if they got FDA approval and get post-approval exclusivity and then have 2nd gen ready to go before that time ran out. With the main Crinone patent expiring 9/15/13 I'm not sure how all the IP issues sort out now. Do they have others to fall back on? Could be a problem if 2nd gen P needs to fight generic "Crinone" for market share.
my understanding is they have been making progress on the next gen prod..if so they tie the formulation so the new trial works along with the most recent trial giving them their 2 trials needed..how could they walk from a branded product they expected to do $350mill + in sales for the cost of a new, most likely U.S. based non-placebo phase III? makes zero sense..as well they mentioned looking to make outright purchases of branded products over the next few months..this is unfortunate but my guess is not over