There are few things in this world more squishy than Wonder Bread. Exception: Biogen’s answers to the question of when it will submit aducanumab to the Food and Drug Administration.
On Thursday, Biogen said a filing for the controversial Alzheimer’s drug would be completed “as soon as possible.” That’s slightly different but no more definitive than the company’s previous guidance for an aducanumab submission in “early 2020.”
It might be worthwhile to mention that a BLA application (or any type of submission for that matter) is no small undertaking, especially with multiple complex clinical trials that I imagine would constitute the aducanumab filing. Even if Biogen threw an admirable amount of talent (in-house and external), the considerable documentation would need to be reviewed, audited and filed correctly. Saying Biogen is being “squishy” about timing and filing seems a tad provocative to me.
The longer Biogen delays filing, the longer they keep their stock up, and uncertainty gives them false hope
To the stock market. Their stock will not decline as long as the possibility of success hangs over it. No hurry then.
If Biogen was turned down, the stock would be crushed.
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