actemra is DOA

It will be total luck if they hold the actemra sales force untill approval, or not.

 

Hmm, I guess companies never lie to employees and never change their minds. They never get more data that changes prior decisions, they never care about the stock price. I guess you are right. Maybe in your free time you can go back for your education degree, you love "teaching" others even though you are clueless. Oh, if you want to go back into education, just a suggestion, teachers don't like their students to use text shortcuts as words, so the BTW will have to go! Good luck at college!

 

The FDA has decided to take another look............we will know the outcome in about six months......Could be another big "Dog and Pony Show".

 

Wasn't it that we had to give them additional trials? I recall it had something to do with fertility issues. The FDA was not going to review further until the further tests were submitted. Has this been done?

 

Yes, obviously.

 

No new human trials needed to be done, just animal trials with pregnancy. Also Roche had to submit a comprehensive plan on how to manage the drug after launch. This is in part because of drugs like Tysabri.

 

The MCR's are no longer going to help promote Actemra, they have a conference call on this tomorrow. What the hell is wrong with this companies mangement? Do they even care about their employees?

 

Since the FDA announced that these drugs cause cancer in kids and teens, and that they need the black box warning - to not use for more than 2 1/2 yrs. Won't that have some affect on Actemra - even if approved. Can it be a blockbuster, with these kinds of problems?

 

The MCRs will land on their feet. Let's hope they get a blockbuster soon.

 

The only blockbuster they will get is going to be pink, There is no way this company (new Genentech) keeps mcr,s around to assist primary care, what a waste of what was once the flagship division of ROCHE

 

If you have been with Roche for more than 6 years you would know what I am spreaking of. I should have said At ONE TIME the mcr position was a very real goal for career advancement we have no current advancement unless you count the very lame FBT now that is worth kissing ass for.

 

This drug is never going to see daylight!

 

What is the latest word on this turkey?

 

MRA Eng and Qual runs anre being made at VV. Tech transfer will move the process and manufacturing to OCN next year. Product has a novel MOA and could be a blockbuster.

 

The RA reps can't sell anyway.....who cares?

 

MRA is being made in VV. Engineering runs almost over. GMP to begin shortly.

 

.....still waiting for that huge upswing.........

 

Eng Runs at VV are not meeting comparability criteria from MRA made at Chugai. Likely the Eng Runs will be extended and the Qual Runs pushed out since the upstream folks can't feed the cells at the right time.

 

Yes, but that's the least of our concerns. None of the safety issues have gone away.