Amylin Regulatory

It seems that more and more people are leaving the RA group. Is there anyone left who is good enough to get Bydureon approved?

 

Certainly not ML. He proves himself to be a total dumb sh*t whenever he opens his mouth. He came to our department to do a presentation and knew nothing about what he was talking about.

 

Prison time for ML if patient should become medically ill.

 

The only thing saving Bydureon is Lilly regulatory.

It is from the top down, ML and the block head directors AA,SE; the Napoleonic complexed chewy when (phonetic pronunciation) and the the rest of the over titled, undereducated, experienced, self aggrandizing group. No one in the group does any work. Not one work product falls under the auspices of regulatory.

Sandra M was not rewarded nor appreciated
Carole E knew what she was doing and was a treat to ML.
HH competent, experienced under appreciated

 

come on. You can do better than that. You are actually being too kind to them. Isn't there anyone else you'd like to bash?

 

Rick Hepp rescuse the company from these idiots.

 

ML needs to be in juvenile detention.

 

Not sure if you are being sarcastic, or part of regulatory trying to deflect attention, but the entire department is incompetent. No ownership, no deliverables, no regulatory opinions, no strategy. Kid you not, department meetings are spent getting out of work, finding other departments on which to transfer responsibilities, just ask anyone in clinical.

 

Yep - standard approach for CMC is to have PharmDev write it, RA then reviews it and bashes how poorly written it is but provides not comments or edits, and then when it sails through the Agency with no issues - RA takes all of the credit for the successful filing. Sounds like the best job ever! I aspire to be a company leach in RA.

 

Overpaid Kinko's employees, the whole regulatory group, copy, format and FedEx documents.

 

Sounds like they are the smart ones for taking your credit while you are busting your ass doing the work. Smack yourself silly for being stupid enough to bend over for them to do it to ya.

 

stop your whining and do something about it if you think you can do a better job. You wouldn't last a day in RA. Our fearless leader is pumped full of tiger's blood and will lead us to victory over you non-believers.

 

Overpaid Kinko's employees, the whole regulatory group, copy, format and FedEx documents.

 

Very funny

 

the Bydureon failure is all regulatory

 

Yea, so Byetta's and Symlin's approvals are all regulatory too. What have you done other than bitching and whining? Get to work on a document (and make sure you do a good job on that) so we can submit and claim credit for that too

 

Wait, weren't they both rejected by the FDA, oh yes. Great job RA! You should pat yourselves on the back for your multiple failures. You FINALLY got it done, that is something to brag about.

 

Uh, not the current RA group. All the talented RA folks that worked on Byetta and Symlin were either let go or have moved on.

 

Experience don't matter. Beginner's luck is what we are betting on. Up your ante for a big cashout.

 

That's perseverance for ya. We get it done no matter how long it takes. What's your claim to fame other than whining and bashing people on this board?