Biotech Values

[zipjet]

>>One of the first analysts to ask questions on the conference call said something along the lines of:
"This is like a 'When did you stop beating your wife?' question. How do you know that your generic product is no more immunogenetic than the branded product when there is no data on what is normal for the branded product?"

The point was well taken. It is even more potent when you know that there is substantial batch to batch variation between Lovenox batches. Which batch do you compare to?

I thought anther interesting take-away from the CC was that there is no "approvable letter" issued in ANDA's. So while the FDA response is in the form of a "not approvable letter" the requests for additional information on immunogenicity is similar to requests received in "approvable letters". As we know approvable letters vary in difficulty from easily produced info to doing more human studies.

ij