Replies to post #62373 on Avid Bioservices Inc (CDMO)

[Protector]

Great, thanks.

Ignore the last part about the Fast Track. I found the answer about that. It may speed things up but apparently still needs a NDA.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf


On the other hand I found this information about the Orphan Drug status interesting because it talks about Phase III tax incentives (that may help to adjust your estimations) and the specific protection Peregrine will get when they market Cotara (Extra patent protection as well as market exclusivity) among others due to it's orphan status (they may support the assumptions of your quite high, but maybe after all not unrealistic market share estimates in view of such protection).

Easy to read:
http://en.wikipedia.org/wiki/Orphan_drug

Official Text:
http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm