Well, I admit having read but not absorbed every word on the CC...just not that into this play anymore. This does answer the broader question I raised evidently puts to rest the patent issue, and Nasrat is on top of it. No problem with that answer.
But, IMO, just must wonder if the FDA had to approve for human use, then if not better to have patented first...unless the substance is known to either be inert or approved in some other capacity. More importantly, however, are my other questions (and that is what they are--questions) regarding how a new formulation will be treated by the FDA with respect to being still under the SOx application waiver per the Priority Review, or if it means we have to do another separate application? And again, what are the implications with Epic and the milestone? They are making enough to get by without R&D, and not burning a ton with it, but are hardly flush with cash. Having to pay a full new application fee and/or if then Epic can walk without paying another milestone (if that is what they choose) could have very negative consequences...though conversely, if it is successful, and has as much cost savings as nasrat says, perhaps they are better forgoing such a milestone and capture all the market w/o the partnership?
I have not seen or heard this discussed nor addressed. IMO, it's quite important given the statements regarding the milestone and timeline in the last report.
GLTY,
Maz
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