What this means for Amylin
This morning we learned that Amylin (NASDAQ:AMLN) received a complete response letter from the FDA for BYDUREON™ their once-a- week version of Byetta. Although this was not the response Diabetic Investor had hoped for, it in no way changes our outlook for what we see as an approval with no black box warnings. In simple terms this basically means we’ll just have to wait a little longer for BYDUREON™ to get here.
The real good news here is that the FDA is NOT looking for any additional pre-clinical or clinical data. Diabetic Investor suspects the main issue is just what the label for BYDUREON™ will look like. Given how Amylin’s shares are performing, currently up nearly 13%, investors are correctly assessing this news as just a slight delay before full approval comes.
Going forward this news really doesn’t change anything for Novo Nordisk (NYSE:NVO) and their once-daily GLP-1 Victoza™. While the company will have some additional time to build Victoza prescriptions it’s unlikely any gains from this delay will be sustainable once BYDUREON™ gets here.
The question most investors are asking today is just how much further will Amylin shares move given their recent and continued gains before this news. As we have noted previously Diabetic Investor believes strongly in the long term prospects for Amylin and sees further gains ahead.
In summary while not the ultimate news, Amylin is moving in the right direction and it’s just a matter of time before they can start sipping the champagne. And it might not be too long after that when another Diabetic Investor prediction comes true when Lilly (NYSE:LLY) finally pulls the trigger and buys Amylin outright.