Biotech Values

[biophud]

New question re ALNY’s new trial.

http://biz.yahoo.com/bw/070417/20070417006082.html?.v=1

1. ALNY is starting development with a combination product.
2. My understanding is that antisense drugs (and RNAi drugs) are treated as chemical entities rather than biologics, and file NDAs rather than BLAs? Please correct me if I am wrong.
3. Several biotechs are researching bispecific antibodies. The papers that I have read state that bispecifics would have a regulatory advantage over combination mono-specific antibodies (i.e. one set of clinical trials rather than two).
4. It looks like the rules are different for chemical entities and biologics? Companies can start combination trials of novel chemical entities but not combinations of novel biologics (?) Please correct me if I am wrong.
5. If my understanding is correct, it would seem that development of combination therapy using antisense/RNAi compounds would be superior to development of combination biologic therapy (from a pure regulatory perspective).

Comments appreciated

biophud