Biotech Values

[tinkershaw]

<<<"Mary Parks, director of the FDA's division of metabolism and endocrinology products, said the agency looked back at Byetta's clinical data and didn't see any thyroid-cancer risk. She also said the agency hasn't detected an increased risk when looking at post-marketing data but also said there are limited data to definitively rule out a possible increased risk.">>>

That is because there is none other then at the highest dose in one species of rodent, in one gender, and if I recall correctly those cells were non-malignant. Not a single person has died from thyroid cancer despite nearly a million people having tried the drug. Not a single person in a byetta or LAR clinical trial has shown any such sign. I have to double check this data, but I believe there was something like 5 in the LIR trial of clinical trial participants.

The data on the two drugs is quite divergent in regard to safety profile. This did come out of left field for most people for NVO so who the heck knows what is in the small print with Byetta. The top line data is not pointing to this generalized class concern. I think more accurately that Lir creates a heightened scrutiny for GLP-1s.

In fact, an AMLN scientific executive was quoted today as stating that the FDA asked for thyroid information on Byetta (and I assume he was speaking of LAR) about a year ago and this executive was puzzled as to why. After the last few days the reason was became crystal clear. It had to do with the scrutiny for LIR, to see if the data on LIR was abberational, or if this might be a class issue. So far the data is pointing to it being a LIR issue and not a drug class issue.

But as always in biotech investing, there is never a moment without worry and fear and doubt and uncertainty so stay tuned.

Tinker