Did anyone look into UBI yesterday? FDA approval announcement and up around 50% on the news.
Their announcement advised both FDA approval and CLIA waiver was granted.
I am wondering why LDX:
- Didn't seek CLIA waiver at time of FDA approval
- Haven't applied for the CLIA waiver yet
- Haven't pushed for CLIA waiver on Febridx given they now have HS on board also
I understand that a complexity of the product needs to be considered however, i would have thought this to be priority for mass expansion into the US.
Ann: Lumos Appoints Henry Schein as US Distributor for FebriDx, page-111
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