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spongepaul

10/19/21 12:22 PM

#240032 RE: jmkobers #240031

The issue of changing the process… Is it difficult to return to the original process to get approval long enough to do a bridging study to prove comparable outcomes in the new process?
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jbog

10/19/21 12:37 PM

#240034 RE: jmkobers #240031

jmkobers,

The timeline really comes down to if we believe Foley or not.

If he truly felt that end of the year was anywhere realistic it meant that Revance didn't feel it had a high mountain to climb to satisfy or correct the deficient components.

If that is true, we'll have to add the defined CRL timelines back into the equation which should be around 2 months for a meeting, 2 months to re-file and 6 months to approve.

My bigger concern right now would be that they'll waste another $250 plus million in the meantime along with the patent lawsuits.

Good Luck