<<<"Exenatide and liraglutide are distinct molecules, so it is not scientifically sound to assume that what is seen with one molecule will automatically be seen with the other," Amylin Vice President Dr. Orville Kolterman said in an interview with The Associated Press.[But the FDA considers c-cell carcinomas a class effect of the long acting GLP-1’s!]>>>
I am not really sure where you are getting this commentary from. In one article the FDA representative was quoting as stating that they looked back at Byetta and saw no signs or indications of any such issue with Byetta.
The animal studies on Byetta LAR are in total contrast to those conducted on liraglutide. Liraglutide showed tumors at every dosage level, in each gender, in each species. Also, you can look at other types of cancers and liraglutide also showed potential signs as well. Where LAR's only c-cell carcinoma in the mouse and rat studies was at the highest dosage level tested, and was considered to be statistically insignificant.
The science is in opposition to the above supposition. Doesn't mean the FDA won't be very suspicious that it might be a drug class problem but the data between Lir and Lar do not back up that supposition.
It is in NVO's interest though, if Lir is to be rejected or delayed for there to be a perception of a drug class link. Lar is a direct threat to not only Lir but also NVO's franchise in diabetes.
Show me the science where the above supposition is supported.
Thanks.
Tinker
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