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Posted On: 07/07/2021 6:26:20 PM
Post# of 153903
from the SEC link:
"In other words, the RTF Letter resulted from the FDA’s conclusions that the Company’s disclosures and presentations in the BLA were deficient, which was the unforeseen result of certain of the Company’s prior regulatory consultants not performing work consistent with professional standards and their representations, including a third party laboratory’s receptor occupancy analysis. "
EFFU Bruce Patterson!
"In other words, the RTF Letter resulted from the FDA’s conclusions that the Company’s disclosures and presentations in the BLA were deficient, which was the unforeseen result of certain of the Company’s prior regulatory consultants not performing work consistent with professional standards and their representations, including a third party laboratory’s receptor occupancy analysis. "
EFFU Bruce Patterson!
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