(Total Views: 571)
Posted On: 12/23/2022 12:57:24 PM
Post# of 153942
Re: Hyperbolic #131882
I’m sure the FDA was not happy with the company back then. Data is data, if anything this entire thing has given me more confidence in the FDA.
After reading the emails, the FDA was clearly trying to do the right thing and help us with the process. NP on the other hand was incompetent, lying or reckless. Whatever you want to call it at the end of the day.
Anyways I think the FDA is doing their job. Look, we will be starting a phase 3 in NASH next year. The FDA will work with us as long as we are doing what they ask. NP and Kaz/Amarex did not giving the FDA what they asked for.
It’s pretty simple. My confidence in the drug hasn’t changed. It was pretty obvious during the last CC that all the SABs feel the same way. I’ll stick with them on this and Cyrus.
After reading the emails, the FDA was clearly trying to do the right thing and help us with the process. NP on the other hand was incompetent, lying or reckless. Whatever you want to call it at the end of the day.
Anyways I think the FDA is doing their job. Look, we will be starting a phase 3 in NASH next year. The FDA will work with us as long as we are doing what they ask. NP and Kaz/Amarex did not giving the FDA what they asked for.
It’s pretty simple. My confidence in the drug hasn’t changed. It was pretty obvious during the last CC that all the SABs feel the same way. I’ll stick with them on this and Cyrus.
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