Regenerate So-So

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anonymous

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Re-analysis is not a disaster, but I think one of two things were needed to get approval,
-10mg gaining significance for improvement and no worsening
or
-25mg hitting on both improvement (which it did) and resolution and no worsening (which it didn't).

Neither happened and safety looks about the same as before which leaves me less than optimistic.
 






anonymous said:
Re-analysis is not a disaster, but I think one of two things were needed to get approval,
-10mg gaining significance for improvement and no worsening
or
-25mg hitting on both improvement (which it did) and resolution and no worsening (which it didn't).

Neither happened and safety looks about the same as before which leaves me less than optimistic.
Click to expand...


I agree. It's too bad 10mg is now basically dead in the water. I think FDA regrets putting the and/or wording in their DRAFT guidance.

Wtf is going on with our stock ... I'm shocked there's no response to this.
 






anonymous said:
I agree. It's too bad 10mg is now basically dead in the water. I think FDA regrets putting the and/or wording in their DRAFT guidance.

Wtf is going on with our stock ... I'm shocked there's no response to this.
Click to expand...

It tells me the street had largely already removed NASH from projections, good news is, if FDA does approve there would be upside, hard to say how much.
 












Why do you say that? Aside from what happened when we got the boxed warning with some HCPS dosing patients that they shouldn’t. Why do you think is it a dog. I am being genuine……fairly new and just trying to learn. Please be sincere
 
























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