Menu
Home
Forums
Forums
Quick Links
Search Forums
Recent Posts
job listings
catering
whistleblower info
legal help
advertise on CP
submit press release
Menu
Log in
Sign up
Search titles only
Posted by Member:
Separate names with a comma.
Newer Than:
Search this thread only
Search this forum only
Display results as threads
More...
Useful Searches
Recent Posts
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Lost Civilizations
>
Amylin
>
Looking for Steve Daly
>
Reply to Thread
Name:
Verification:
Answer the above question:
(
CustomImgCaptcha
By
Surrey Forum
)
Message:
<p>[QUOTE="Anonymous, post: 4636286"]I know it's a "no brainer", but I strongly agree that Amylin tanked when Ginger Gramham left and Dan Bradbury took over as President and CEO. The whole culture and management style of the company changed. Amylin went from being "One of the Best Places to Work in San Diego" to zilch. </p><p><br /></p><p>Amylin was a place employees were happy to go work and excited about the work they did. It became a place where employees held on, endured the day, and lived on hope and the memories of better times. Maybe, just maybe if Bydureon could get approved by the FDA, and the sales did hit the numbers we had been told about so many times over the years, the good times would return. Dan and Orville would retire in glory. The management that would follow them would follow in Ginger's footsteps and Amylin could reach its real potential with the great employees that had worked on her breakthrough drugs.</p><p><br /></p><p>This was not to be. Because Bydureon's road to approval was paved with lies: Lies to the FDA, Lies to the employees, and Lies to the investors. The entire "we had no idea about the need to do heart study for Bydureon" circus was a lie. </p><p><br /></p><p>Here is a sample of what I learned from from a few excerpts in a 6/25/12 article by Adam Feuerstein </p><p><br /></p><p><a href="http://www.thestreet.com/story/11595037/2/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://www.thestreet.com/story/11595037/2/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html" rel="nofollow">http://www.thestreet.com/story/11595037/2/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html</a></p><p><br /></p><p><br /></p><p><br /></p><p>"SAN DIEGO (TheStreet) -- Amylin Pharmaceuticals (AMLN_) concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence, newly released FDA records show." </p><p><br /></p><p>"Later, Amylin executives lied to investors by failing to disclose that this hidden Byetta heart-safety study played a key role in FDA rejecting the company's follow-on diabetes drug Bydureon, according to these same FDA records."</p><p><br /></p><p>"One month later, in April 2010, regulators with Health Canada told FDA about a "thorough QT study" of Byetta conducted two years earlier by the company. So-called tQT studies measure the effect a drug has on heart rhythm, an especially important issue to FDA given concerns about the cardiovascular safety of diabetes drugs. This tQT study of Byetta raised significant heart safety concerns for Canadian regulators."</p><p><br /></p><p>"But Amylin had never told FDA about the tQT study of Byetta and failed to include the troublesome heart-safety data in the initial Byduron approval filing. Amylin withheld these negative safety data even though Amylin agreed to supply FDA with Byetta efficacy and safety data for use in the Bydureon review, FDA's Parks charges in her memo."</p><p><br /></p><p>How many times did we sit in employee meetings as executives told us how bewildered they were by the request from FDA for the tQT study? How many jobs and lives have been impacted by this lie? Of course, the people who told the lie are doing just fine, thank you. Are you?</p><p><br /></p><p>Yes, this is old news, but I have to admit it was news to me.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 4636286"]I know it's a "no brainer", but I strongly agree that Amylin tanked when Ginger Gramham left and Dan Bradbury took over as President and CEO. The whole culture and management style of the company changed. Amylin went from being "One of the Best Places to Work in San Diego" to zilch. Amylin was a place employees were happy to go work and excited about the work they did. It became a place where employees held on, endured the day, and lived on hope and the memories of better times. Maybe, just maybe if Bydureon could get approved by the FDA, and the sales did hit the numbers we had been told about so many times over the years, the good times would return. Dan and Orville would retire in glory. The management that would follow them would follow in Ginger's footsteps and Amylin could reach its real potential with the great employees that had worked on her breakthrough drugs. This was not to be. Because Bydureon's road to approval was paved with lies: Lies to the FDA, Lies to the employees, and Lies to the investors. The entire "we had no idea about the need to do heart study for Bydureon" circus was a lie. Here is a sample of what I learned from from a few excerpts in a 6/25/12 article by Adam Feuerstein [url]http://www.thestreet.com/story/11595037/2/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html[/url] "SAN DIEGO (TheStreet) -- Amylin Pharmaceuticals (AMLN_) concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence, newly released FDA records show." "Later, Amylin executives lied to investors by failing to disclose that this hidden Byetta heart-safety study played a key role in FDA rejecting the company's follow-on diabetes drug Bydureon, according to these same FDA records." "One month later, in April 2010, regulators with Health Canada told FDA about a "thorough QT study" of Byetta conducted two years earlier by the company. So-called tQT studies measure the effect a drug has on heart rhythm, an especially important issue to FDA given concerns about the cardiovascular safety of diabetes drugs. This tQT study of Byetta raised significant heart safety concerns for Canadian regulators." "But Amylin had never told FDA about the tQT study of Byetta and failed to include the troublesome heart-safety data in the initial Byduron approval filing. Amylin withheld these negative safety data even though Amylin agreed to supply FDA with Byetta efficacy and safety data for use in the Bydureon review, FDA's Parks charges in her memo." How many times did we sit in employee meetings as executives told us how bewildered they were by the request from FDA for the tQT study? How many jobs and lives have been impacted by this lie? Of course, the people who told the lie are doing just fine, thank you. Are you? Yes, this is old news, but I have to admit it was news to me.[/QUOTE]
Your name or email address:
Do you already have an account?
No, create an account now.
Yes, my password is:
Forgot your password?
Stay logged in
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Lost Civilizations
>
Amylin
>
Looking for Steve Daly
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Lost Civilizations
>
Amylin
>
Looking for Steve Daly
>