80’s music
We can dance if we want to!” Kim’s Bat Mitzvah was the wildest par-tay a mile away!!!!!! It totally r0×0red!!!!!!!!!!!!!!!!!!
Kim and I requested a lot of 80’s music, like the safety dance (but i think mandy requsted that), rock lobster, whip it, unbelievable, tainted love (i looove that song), ermmm some more too.
New Position!!
I am now looking for a Director of Regulatory Affairs for a Biologics company in NC. This company is looking for someone with about 8-10 yrs experience in dealing with CBER and writing BLA’s.
posted by Mike Trowbridge/MRI Raleigh @ 10:03 PM 0 comments
Second Non-Approvable Letter
Forest Laboratories, Inc. , an international pharmaceutical manufacturer and marketer, today reported that the U.S. Food and Drug Administration (FDA) has issued a second non-approvable letter for the indication of Panic Disorder for Lexapro(R) (escitalopram oxalate), an SSRI antidepressant. The Company indicated that the letter was pursuant to an FDA review of its response, dated August 2004, to an initial non-approvable letter which raised issues related to methods and statistical analyses performed for the two placebo-controlled trials provided in the submission. The Company is currently reviewing the FDA’s response in order to determine the appropriate action regarding the Panic Disorder submission. Both studies included in the submission have been previously published in medical journals. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults.
bitch wrote it off as a zit, but she was obviously disgusted with me, even through her Botox face I could read it…
// posted by o @ 12:01 AM
7.01.2003
Winding Up
Well I made it through “finding nemo” without stealing popcorn out of the hands of the 4-year old I took to the movie, though he was trying to get me to eat some–they start early. I chomped on my 30 pistachoes in the dark, sucking the salt of the shells, washing it down with my $100.00 diet coke.
Came home, famished, which is annoying since this already skinny lady in my office who is doing the SBD for those pesky last 5 lbs (pet peve–I mean, she should be in the 25+ club to join) claimed she was never hungry in Phase I, I wanted to say “you are probably never hungry anyway,” but she is actually pretty nice. So I managed to George Forman a chicken breast with chii garlic paste, soy sauce,and some ginger-total ghetto gourmet, and I even steamed two artichockes, and I rosted that caulflower for tommorrow- and it tastes AWESOME! Garlic, olive oil,
I think Jeff was drunk or that sugar he had totally worked. Maybe both. Kim and I tangoed a few times and just danced like freaks.. I dosie-doed with Mandy, Kim, Lauren, April, and Miriam. I danced for a min. with Mandy. And I tried to get matt to dance with Jeff. ( like were outta this world!!!) When the Safety Dance was on but Jeff and him wouldn’t so everyone else just danced like they were outta this world and looked at matt’s pants!! It was really really really fun and wish it had lasted longer..’till like 2 AM as Jeff suggested, but Jeff’s a bit messed up…..”We can dance if we want to, we can leave your friends behind, ’cause if your friends don’t dance then the’re no friends of mine!” It was nice seeing friends like Matt and Miriam who I haven’t seen in a while.