I finally have a chance to read the entire letter carefully line by line. My impression is as follows:
(1) I like what I read regarding the efficacy of Xopenex. It is very clear that 0.625 mg does the trick of 4X (2.5mg) albuterol and SEPR does have a better mouse trap, hands down.
(2) The letter reminds me of the response I got from reviewers of the patent office who pick out words and phrases that they deem incorrect, or too board, too vague etc etc. Most such compliants are just trivial ,trivial, and trivial. However, the FDA apparently dish out labelling the same way as issuing a patent because of the legal implication of the language.( Too board, too vague, claiming too much etc etc ! ). However, in the case of Xopenex, it is not a matter of claiming too much, it is a matter of how one phrases it. May be SEPR should hire me to do some writing for them. I know how to get around those jargon problems after having filed and fought for 7 patents.(No,just kidding, not looking for a job).
If anyone sells because of this letter, they ought to take another look at the letter and then have their heads examined.The four directors selling is a different story. I still hold them responsible for creating an uncalled for panic. |
