If the only issue is the packaging / instructions, why is this going to take PXS/Chesi over 6 months to reply to the FDA?
Ridiculous.
In the meantime, the sell-down - death by a lots and lots and lots of little trades at a time- continues without respite.
Sigh
Ann: Pathway to US Bronchitol Approval Clarified in FDA Response, page-42
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