NP said they will negegtation with the FDA on the
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Posted On: 04/17/2019 2:49:43 PM
NP said they will negegtation with the FDA on the safety data, once they get a answer, then the timeline will be more solid and an update will be posted.
Maybe the negeations involves including these 30 combo patients for safety data.
If you look on Feb 1st, assuming they switched the 30 combo patients to 700mg, as the FDA allowed. They had 45 + 29 +30 =104 patients on 700mg. 24 weeks after Feb 1st is July 19th. They enrolled more 70-90 patients after this PR in February, early March. So how many of what types the FDA allows at the 700mg level will determine the timeline: starting 700mg initially, switched to 700mg on mono, switched to 700mg on Combo.
Mono 700mg 45 enrolled started with 700
Mono 700mg 29 from originally a lower dose
Combo 700mg 30 ( NP gave this number in noblecon) permission to switch to 700mg
Read More: https://investorshangout.com/post/view?id=541...z5lNalujZe
Maybe the negeations involves including these 30 combo patients for safety data.
If you look on Feb 1st, assuming they switched the 30 combo patients to 700mg, as the FDA allowed. They had 45 + 29 +30 =104 patients on 700mg. 24 weeks after Feb 1st is July 19th. They enrolled more 70-90 patients after this PR in February, early March. So how many of what types the FDA allows at the 700mg level will determine the timeline: starting 700mg initially, switched to 700mg on mono, switched to 700mg on Combo.
Mono 700mg 45 enrolled started with 700
Mono 700mg 29 from originally a lower dose
Combo 700mg 30 ( NP gave this number in noblecon) permission to switch to 700mg
Read More: https://investorshangout.com/post/view?id=541...z5lNalujZe
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