Thank you Lorbas for looking , very good memory..
Post# of 148292
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Posted On: 11/25/2019 6:44:55 PM
Thank you Lorbas for looking , very good memory...
) !!!!!
OK so Dr NP said " data is submitted to FDA ", so if " is " mean is already done , that is ok , but FDA must have everything including safety profile for 700 mg before they will make this decision....
The good news is FDA will do already so much of work on our BLA , that hopefully we will not need to wait 6 months for approval.
And that's the least FDA should do for our patients.
I am also hoping that Dr Stefano Ruscani from Milan work , included with our BLA , work with the most sick patients with MDR 4 , and results with Leronlimab , will push FDA to even faster work towards approval.
IMO as always.
) !!!!! OK so Dr NP said " data is submitted to FDA ", so if " is " mean is already done , that is ok , but FDA must have everything including safety profile for 700 mg before they will make this decision....
The good news is FDA will do already so much of work on our BLA , that hopefully we will not need to wait 6 months for approval.
And that's the least FDA should do for our patients.
I am also hoping that Dr Stefano Ruscani from Milan work , included with our BLA , work with the most sick patients with MDR 4 , and results with Leronlimab , will push FDA to even faster work towards approval.
IMO as always.
(2)
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