Biotech Values

[biotech jim]

I made the following post on SI regarding the background on DEA labeling and some of the attributes of eluxadoline.

http://www.siliconinvestor.com/readmsg.aspx?msgid=29510816

I actually thought my post here would be challenged a bit, since I also feel that schedule V is a possibility as it is an opiate drug. My rationale for no or schedule V labeling relates to low systemic absorption (a locally acting drug in the GI system), and limited or no abuse potential in animal studies. It was indifferent from PBO in 'drug-liking' behavior, and in dis-liking behavior it was significantly dis-liked compared to PBO. These data were presented at the ACNP meeting in Dec 2013.

I do not know of any published study or SEC filing that discusses human or preclinical species systemic absorption, or CNS penetration after IV injection of the drug substance. The company has these data, but has stated that the drug has "limited systemic availability."

Now the FDA does have a somewhat unwritten protocol on how they determine whether a substance is 'labelled' or not, and I have to take the DC metro shortly so I do not have time to go into detail on that right now. And of course I was not present for the company's discussions with the FDA on potential labeling.