Amylin Regulatory

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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.
 
Anonymous said:
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.
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Prison time for ML if patient should become medically ill.
 
Anonymous said:
It seems that more and more people are leaving the RA group. Is there anyone left who is good enough to get Bydureon approved?
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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
 
Anonymous said:
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
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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?
 
Anonymous said:
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?
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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.
 
Anonymous said:
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.
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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.
 
Anonymous said:
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.
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Overpaid Kinko's employees, the whole regulatory group, copy, format and FedEx documents.
 
Anonymous said:
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.
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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.
 
Anonymous said:
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
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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.
 
Anonymous said:
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.
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Overpaid Kinko's employees, the whole regulatory group, copy, format and FedEx documents.
 
Anonymous said:
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
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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.
 
Anonymous said:
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
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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.
 
Anonymous said:
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.
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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?
 


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