Re Update:
FDA said had questions and would ask questions. Check
FDA asked questions. Check
PAR said would be ready to answer questions and would advise when questions received. Check
PAR provided update/ Check
I think the key phrase is 'the agency also provided its suggested mitigation strategies to address its position and questions'...
Don't think we really got anything other than what was expected. No reason to be negative IMHO.
The SP will do what it will do, but strategy remains to buy weakness.... DYOR
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- Ann: IND QUESTIONS RECEIVED FROM US FDA
Ann: IND QUESTIONS RECEIVED FROM US FDA, page-8
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