Replies to post #26270 on Biotech Values

[DewDiligence]

Thanks for the added color.

>Does anyone have a sense of the regulatory hurdles that will have to be overcome with the FDA for say, ocular delivery of siRNA therapeutics?<

Just the usual ones, IMO. E.g., for Sirna-027, the RNAi-based drug for the treatment of wet AMD from RNAI and AGN, I expect the FDA to ask for the standard data package in this indication: two large, randomized trials, each with two years of treatment. If the safety data are clean, an NDA submission based on efficacy after only one year may be permissible.

[poorgradstudent]

>In fact, are there any approved drugs which target RNA other than antibiotics?<

Vitravene:

http://www.fda.gov/cder/consumerinfo/druginfo/vitravene.HTM

But I don't think anyone is investing in RNA targeting technologies because of vitravene. It's been a commercial flop.