<< "We don't view this as something that is unusual or daunting or larger than usual" said Jean Nichols, president & chief technology officer at SRGN. " This is primarily clarification" of the company's studies, she said."It's not new data, not new trials."
Versus:
<< The letter identified certain deficiencies in the application related to safety, efficacy, manufacturing and product characterization. >>
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Well, which is it, clarification or deficiencies?
One key, is that the FDA did it on the last possible day. The "deficiencies" part of the review letter could be standard language used.
Anyway, good to hear about the lack of after hours trading. Perhaps, the news of the letter is what put a lock on LGND today.
By the way, how was the around the world blitz?
Regards, Bob |
