News Focus
News Focus
Replies to #32022 on Biotech Values
icon url

xrymd

07/29/06 10:28 AM

#32025 RE: 10nisman #32022

I do not own any ENCY but have thought about purchasing after the latest decline. I think they will get the full approval probably after negotiating a post approval phase 4 study. There are other treatments for PAH including viagra. Myogen is hot on the heals of all the current meds but they haven't had there day in FDA hell yet. The reason I held off in purchasing ENCY is that it is unclear to me that the market for PAH collectively for all the products will be billions of dollars (someone correct me if I am wrong).

I have recently bought DSCO another example of two approvable letters from the FDA at an average cost of about $1.90. I believe their product is superior to current available products (the data supports this) and I think they will get the manufacturing right (eventually, hopefully!!).

icon url

drbio45

07/29/06 11:30 AM

#32027 RE: 10nisman #32022

ency

I own it and I can understand why Dr. Given wouldn't want to let the competition know what his problem is. If they run into the same problem in a year why should he let them prepare for it now.

if he doesn't get the approval then he didn't lose anything by not telling

He was optimistic on the call that he wouldn't need to do other trials. but that may not mean anything

Most drugs do not make as much money in Europe as they do in the United States because reimbusement in Europe is not as good. A competitor has a drug, Tracleer, approved in Europe that has reimbusement similar to the US. Encysive will probably be launched in Europe shortly. The market cap is probably fair to undervalued just for the European business, so that should give downside protection even if the FDA doesn't approve it in the US

The reason I believe that it should be approved here is because according to all of the data out there including the fact that Encysive even did a study where they did a head to head of their drug vs Tracleer, Encysive's drug Thelin, was clearly safer and had better efficacy than Tracleer.

It would be logical on that basis to assume it should be approved but logic doesn't always work when dealing with the
FDA.