I wonder if suspension of PARA-005 and SASS have something to do with the "safety issues" flagged by the FDA, since I doubt these delays are covid-related.
It's difficult to know how significant these tissue findings are since the company has released scarce details about them and appear to be deliberately withholding this information, which could be deemed market sensitive information if the FDA does not approve the IND, on the grounds of safety, in the next few weeks. In this case, PAR could be in some trouble.
On the flip side, I presume PAR have already submitted their responses to the FDA, which will also include a statement from a clinical expert stating that these tissue findings are not clinically significant or clinically relevant, further supporting PAR's stance and which I expect will appease the FDA.
I know there are people on this forum that know the answers to these questions, but I guess for the rest of us will just have to wait for another 3 weeks.
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