Harry:
>> But if so, that is an alternate hypothesis to 'they were lucky' <<
He's not saying that they weren't skillful. He's saying that they were fortunate that the structure isn't one of many described "shotgun" by Wyeth. You're both correct.
CRF..... drool. Thanks for the update.
sustained release......
>> If it is in fact so easy to devise an alternate time-release technology that does not infringe, but provides identical bioavailability and pharmacodynamics/kinetics <<
But is that necessary? I don't understand why an alternative TR formulation would not be acceptable to FDA. You're saying that a "generic" competitor would need to go back and do phase I and II testing, and that would be a daunting hurdle. But that's in a context where those trials would be followed by a large, risky phase III??
Wouldn't it just be a matter of providing sufficient evidence of efficacy in a context where tissue accumulations do not exceed those characteristic of any DOV/ELN formulation?
rkrw knows a lot about this sort of stuff, no?? I don't, and I'm just offering my thoughts up as fodder. Make me look silly, make me wealthy.
:-)
bicifadine...... this is important, obviously. As you indicated, the acute dental pain indication is not the target.
>> 2) They have filed for patent on the crystalline structure of bicifadine--and say that any alternate stucture immediately degrades to their's, thus infringing on their patent-pending. (similar to structure strategy successfully used by NBIX on Indiplon) <<
I believe that you're (mostly) saying that there is a patent strategy in place to keep a generic competitor tied up in court, not allowing them to use DOV/ELN data with the non-TR versions as a part of any submission? Isn't that, given the current view of patent manipulation (e.g., Waxman-Hatch), a bit risky to invest in? I'm hoping that our new FDA commissioner is charged with responsibility to make good drugs "available cheap", and to recognize innovation and development expense by allowing new, good drugs "available expensive".
:-)
Fun/spooky to poke around here......
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