Total BS--ARNA does not drive the EU approval boat. In fact, all indications from the CHMP are that Belique approval is very iffy: lack of required diet run-in period, dissatisfaction with ARNA's answers to the 120 day questions, the requirement for an oral presentation, and the late stage where we are in the 210 calendar.
Disclosure: Extremely long ARNA 2014 leaps but not blinded by the prospects for EU approval
Can anyone here answer this question? Say the USA launch begins and sales are starting , say around march 1. Using the same scenario along with 2 different EU scenarios. first, EU rejects or asks for more info as opposed to the 2nd, EU approval. What would the sp be on march 1 with each of these possible scenrios? In other words, how much impact does EU have on ARNA going forward? Sensible answers only please.
No. I believe there are several options to change the risk profile of Lorcaserin such as RMP or the equivalent of REMS type of program. The EU has virtually required an RMP on every new drug entity. This is the role of the PRAC committee.I have regained my confidence they will be approved.