Zipjet, courts understand the reality of how people communicate and that corporate statements are often fill of fluff, optimism, gamesmanship, or whatever terms you want to utilize. I've been in front of too many judges who bend over backwards to put these sort of statements in context. So I believe Dew's statement to be accurate.
This said, that letter TEVA received suddenly becomes very material in the context of TEVA's prior statements, and just the fact that the issues presented on it get to the gist of the issue.
I don't see how TEVA cannot turn over letter at this point, if the issue is how close or imminent FDA approval is. It will be interesting to see if we, the public, actually get to learn the substance of the letter.
Tinker
P.S. Just an observation. If the questions were minor, at this point in time, TEVA has every incentive to let the world know of their imminent approval from these minor issues. As I stated earlier, this defense goes away upon commercialization, so why continue to play this defense if commercial approval is expected. They will have to produce the discovery at that point in time anyways. I don't recall MNTA having any problem commenting on the immunogenicity issue. Makes you wonder why TEVA so fervently maintains this defense, and gives no indication at all as to what the deficiencies are other than citing the irrelevant "minnor" term in the letter. But more conjecture, I know.
AI
