Listned to the CC from yesterday and sounds like all is well. Most of it we already know, but there was a nice little gem thrown out about talks with the FDA on Orphan Status. This got my attention.
Incentives to orphan drugs providers in terms of R&D, intellectual property and marketing
Granting orphan drugs status may enable the sponsor to obtain the following advantages for the development of the product :
a 50% tax credit on the cost of clinical trials undertaken in the USA ;
a seven year period of marketing exclusivity following the marketing approval ;
some written recommendations provided by the FDA concerning clinical and preclinical studies to be completed in order to register the new drug ;
a fast-track procedure for the FDA to evaluate registration files ;