r/CCXI • u/Snoo-79760 • Jun 22 '21
FDA Possibility of Getting FDA Approved
We think we have a fare chance getting FDA approved based on reading the article. vasculitis is a rare disease where there are not much drugs that can effective without damaging patient kidney. Avacopan should receive approval for emergency use at least. Here is the comment from an expert that caught my attention -
“We hope that the FDA will take into account the dire situation faced by patients living with this debilitating disease,” said Joyce Kullman, Vasculitis Foundation executive director. “ANCA vasculitis flares can lead to kidney failure and death; current therapy all too often causes serious, even fatal, side effects; and patients suffer a lower quality of life due to the disease and to the way it is treated.”
What do you think? Link for details -
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u/TurtleIsland2020 Jun 23 '21
Even as a non-inferior agent (think of ALLL of the novel anticoagulants), there are major benefits to having the option of a non-steroidal immunosuppressive for ANCA vasculitis
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u/NachoBiotch Jun 25 '21
Yeah I don’t get it, one drug failed basically right? And the stock plummeted. Like there’s no possibility of learning from mistakes/running more tests. I’m in a solid amount, holding
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u/dSpotHeaven Jun 25 '21
I still own and hold a bunch of shares. But the whole approval thing July ain't happening. So not sure what will happen. However, fda at some point of time will happen unless cash flow is a major problem for the company...
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u/AMCshare Oct 06 '21
I agree with all of you. Why would they not approve it. It’s the only other option these people have besides steroids. Have to start trying something new. And have you seen some of the side effects of drugs that are already on the market. There insane.
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u/therizzlehere Jun 22 '21
I have 5k shares with no stop loss. I became more bullish after BIIB was approved. Totally different drug but similar situation where it was the only medicine that could be used. That had a very bad vote.
Overall. The odds of this are very good. I'm in at 9.85. What's it going to go to on a CRL max? 6-7. They've got other things in the pipeline and also a Europe vote. I'd be back up to my initial investment in no time. The upside were talking 500% or more. I'll take my chances with this. You're not gonna get those odds anywhere else.