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Posted On: 11/21/2019 7:28:43 AM
Post# of 149255
Knowing that patients HIV positive , especially patients using HAART do develop NASH more often , especially when Tenofovir is in use ..
I really hope that if we will need to do pivotal mono , we will also do NASH study on the side with the same patients...,
The only thing we will need is some extra evaluation of liver ....
This could be perfect study to observe liver function !!! and total liver during our monotherapy ...,,
Even if it will not be officially call phase 2 clinical study for NASH.
The information collected without doing much extra work , except some liver evaluation will be unbelievable .,
And actually FDA may give as phase 2 for it ..,,
imo always
I really hope that if we will need to do pivotal mono , we will also do NASH study on the side with the same patients...,
The only thing we will need is some extra evaluation of liver ....
This could be perfect study to observe liver function !!! and total liver during our monotherapy ...,,
Even if it will not be officially call phase 2 clinical study for NASH.
The information collected without doing much extra work , except some liver evaluation will be unbelievable .,
And actually FDA may give as phase 2 for it ..,,
imo always
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