To be fair, it's difficult to hit when FDA keeps m
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Posted On: 02/06/2020 5:23:12 PM
Re: bwolfy2002 #17193
To be fair, it's difficult to hit when FDA keeps moving away the goalposts...
I honestly don't know what all these (pre-)BLA meetings are good for; doesn't put a good light on FDA: They could have said which data they wanted months ago (basically all, even if not related to combo)... I too fear that BLA submission will be dragged long into March.
Luckily, cancer data will hit continously, which provides protection against too much downside. But clearly, the later revenue starts this year, the more debt/dilution will be required, since the China deal - if they reach a definitive agreement - is likely to take a few months to negotiate.
I honestly don't know what all these (pre-)BLA meetings are good for; doesn't put a good light on FDA: They could have said which data they wanted months ago (basically all, even if not related to combo)... I too fear that BLA submission will be dragged long into March.
Luckily, cancer data will hit continously, which provides protection against too much downside. But clearly, the later revenue starts this year, the more debt/dilution will be required, since the China deal - if they reach a definitive agreement - is likely to take a few months to negotiate.
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