Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer
CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval
Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to patients in the U.S.
Atara has engaged a well-known financial advisor to support exploration of all strategic options
Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders
Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval
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