RE: Teva lawsuit / CMC
Thanks Dew.
Wheeler said the following below (from Fmmm's post). When he mentions CMC, does this not imply that Teva will have to use the technology (characterize the structures) during manufacturing, once (rather "if") the product is approved? If it were just for a lot used in approval,or somehow to demonstrate the process yields the product, would you call it CMC? Actually, Wheeler even says "release standards". If that is really what FDA requires it would be great.
O.
Wheeler:
Quote:
"Of course, when we saw the FDA's Citizens' Petition Response, I was in one way thrilled, in one way very concerned [I am sure concern is to be taken in the "pleased" sense if that is possible ].
I was thrilled that they actually took advantage of our technology and approved a drug. And, business the other side of it is that there are many things buried in that petition. There are clearly -- are things that we own patents to, and therefore want to protect. So when we looked at that and saw that they were expecting those around manufacturing controls and release standards, and that Teva was out there saying, we're now manufacturing inventory for launch, it created an opportunity for us to actually assert those patents."
Market Data 
Markets 
AI
