Provention Bio, Inc. (PRVB)

[sokol]

“…. the FDA stated that a single, low-dose …. failed to show PK comparability.” What will multiple and/or higher doses show? “ The Company expects relevant additional PK/PD data being, or to be, collected from a substudy in patients receiving 12-days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients…”. The Seeking Alpha article indicated the company believes product quality has been addressed. Product quality should be easy to remedy. The only thing I am concerned about is what will the additional PK/PD data show? I will continue to hold for now. Biotech is volatile, and this is another example - look for anything that indicates that additional or higher doses may work?

It is often said that it is all about dosing. Designing the correct dosage regimen is important for achieving the desired therapeutic efficacy and avoiding undesired effects. Additionally, this is a biologic. Possibly the drug may work differently for different patients. The amount of dosing, dosing frequency, number of injections, and time to onset of effect, etc., are but a few factors involved in the administration of this biologic. Biologics, like many things, I think are complicated.