Zuranalone Launch

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anonymous

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Question for those waiting their fate on Zuranalone launch.

What is everyone hearing? I will start.. I heard 4-6 weeks for the company to decide new strategy and sales force size before offers are extended.
 






anonymous said:
Question for those waiting their fate on Zuranalone launch.

What is everyone hearing? I will start.. I heard 4-6 weeks for the company to decide new strategy and sales force size before offers are extended.
Click to expand...

I heard the same. I also heard there is a clause where Biogen can back out and let Sage launch.
 






anonymous said:
I heard the same. I also heard there is a clause where Biogen can back out and let Sage launch.
Click to expand...

One article said Biogen could completely back out. But one of my sources at Biogen said they are needing to bring this to market.. so I guess only time will tell!

Something else to consider, is that no one has seen the CRL. It’s not made public so what the FDA is needing for MDD has not been made public other than speculation. It will truly depend on that as well. Will they be able to give them additional information for them to make a decision or will they have to complete a whole new study? They were hoping to study it for anxiety and bipolar as well.
 












A complete response letter from the FDA is the end. Company does is not obligated to divulge the letter's contents to the public. But MDD is done. that is why it is a "complete" response.
 












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