Voclosporin will likely be approved well before the P3 trial runs it course. Here's how it's going to work. First, there's a legal and regulatory path for this approval . While I quote the relevant passage below, here's the link to the FDA Regulations , as well as a list of drugs t hat received accelerated approval. Sec. 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoin t that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that ...
TC, please dont hold back, tell us what you really think lol. Fwiw, you are 1000 percent correct imho.
ReplyDeleteI'll confess I might have been a bit too restrained, and will be more forthright in the future.
DeleteGrandma caused me to delete the iHub app. Something is not right with that person. I stick to StockTwits now. iHub is unusable.
DeleteAurinia Pharmaceuticals Inc
DeleteBan List
Member: grandma_of_jbraika
Date Banned: 09/10/2017 09:35:33 AM
Banned By: IH Admin [Edward]
Banned Until: Further Notice
Looks like asshole number 1 was banned from Ihub (grandma). Now they should ban asshole number 2: BR
ReplyDeleteStill a buyer in the 5's
ReplyDeleteApparently there are multiple indications coming in October. This may be the last time to get in low before the sp begins its ascent.
ReplyDelete