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stoneroad

07/06/19 1:12 PM

#200168 RE: MedResCollab #200166

We, we, we all the way home. Who the F is WE? Please do tell.

HDGabor

07/06/19 1:54 PM

#200177 RE: MedResCollab #200166

M-

we should have a clear idea over the next two weeks

It "should be" one week … and could be Monday (but let's say Tuesday morning)

we think it will have a modest impact

I understand your thinking but be real … it does not have any impact … it is in the trash already (where to belongs).

It isn't cost you anything (e.g 32k) but you could use:
- PR (done)
- no AdCom (more likely we will know by Mon / Tue but as the latest by Friday)
- approval (on or before Sep 27 … no AdCom announcement could contain expedited review determination also …)
- the CP will be denied

Best,
G