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Re: None

Tuesday, 02/09/2016 2:00:20 PM

Tuesday, February 09, 2016 2:00:20 PM

Post# of 16885
It means nothing if probuphine isn't approved, but...from the Braeburn company overview presented at the JP Morgan conference, they are planning a 3Q 2018 launch of probuphine for chronic pain. That would mean approval occurring probably no later than 2Q 2018, with an sNDA submitted sometime in 2017.

From the Section 6.1 of the Braeburn License Agreement, regulatory milestones are paid for

(ii) Submission of NDA for Subsequent Indication of chronic pain
***
(iii) FDA Approval of NDA for Subsequent Indication of chronic pain
***

...so for those who are counting their chickens before they hatch, there should be a regulatory milestone paid in 2017...I would guess $10 million or so. That value has not be factored in by Zachs or anyone else.



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