Replies to post #75817 on Biotech Values

[tinkershaw]

<<<Tinker, there are 2 sets of preclinical data: those of Byetta and those of the once-weekly version. As I posted here #msg-36816635, based on Byetta's preclinical data with regards to the c-cell growth, I thought AMLN could get away with the issue. However, LAR's 2 year rat data (note that AMLN didn't test in mice at all) are not so different from those of liraglutide as these two long acting GLP-1s showed stat-sig increase in c-cell adenomas in both sexes and a stat-sig increase in c-cell carcinomas only in one sex (only at the highest dose).>>>

I will have to look into this. I have reviewed the Lig briefing report and the discussion of byetta and the mouse and rat data that was presented. It is tough to separate out Byetta BID from Byetta LAR data as everyone continues to lump it together.

From the briefing report I found this possible concern: http://www.investorvillage.com/smbd.asp?mb=2885&mn=57873&pt=msg&mid=7032274

I will have to review through here more carefully to try to unmix the BID and LAR animal study information. The FDA itself did not necessarily do a good job of that either. Probably because it is Lig and LAR that is up for review here, but they make little distinction in this briefing between BID and LAR.

Tinker