RE:RE:Earnings CallThanks, but the press release suggests the BLA submission wasn't as compele as we believed it to be. I wonder if word of this got out weeks ago and encouraged this short attack. I, being a foolish optimist, have been hoping they will pull a rabbit out of the hat with news of partnership discussions, so this does shake me a little.
From the news release: The Company recently submitted a response to an information request from the FDA related to the BLA resubmission. On November 6, 2020, the FDA notified us that the submission of this additional information by the Company constituted a major amendment because the submission contained substantial new manufacturing or facility information not previously submitted to or reviewed by the FDA, which entitles FDA to extend the review process by three months.