SOBRE ARNA, interesante post de un usano
am trying to connect the dots in respect to possible EMA approval and all indications suggest a favorable outcome:
1) Belviq has already been greenlighted by the FDA.
2) The three EMA questions (per CC) are the basically the same questions the FDA had and has been thorougly answered.
3) Belviq is manufactured in Europe. (good politics never hurt).
4) Obesity crisis is also a serious health consideration in Europe.
5) It does not cause birth defects (wink, wink at VVUS).
6) Safe and efficacious drug.
We will get EMA approval and with that in hand in conjunction with FDA approval, Belviq will pretty much corner the rest of the world (ROW) in the obesity space. This is what it takes to become a MEGA BLOCKUSTER DRUG.
My political post analysis from a few months ago also gave me confidence in the FDA approval. For those who missed:
The political connection that convinced me that Lorcaserin will be approved
Margaret Hamburg was an Obama political appointee who is VERY close to the Obamas. Like President Obama, she is from Harvard. Like the president, she is also of mixed ethnicity. From that standpoint, you can start to understand how connected these people are.
Forget whatever recent statements she may have made irt to obesity epidemic. Anybody can say anything without really meaning (i.e. Von Eschebach's famous bridge to nowhere).
In Hamburg's case, however, I really believe she is determined to do something to help obese patients. She has publicly echoed Michelle Obama's concern regarding obesity. In public office, as in private, if the top dog wants something done, it will be done. Simple as that.
The FDA cannot only approve Qnexa without depriving a very large segment of the population (women of bearing age -- 16 to 48 years) of an obesity treatment. This is vhere Lorcaserin comes in with its safe, efficacious profile. Today, the setup for Lorcaserin approval could not be more perfect with the political winds in their backs.
Not too long ago, there were / are analysts, who believe none of the obesity drugs would ever get approval. If the hedgies are relying on that sort of outdated information, they will lose a lot of money in the coming days, weeks or months. If they are truly smart, they should cover their short positions and go long.
Tonight, I am more convinced than ever that Lorcaserin will get a relatively fair hearing on May 10, with subsequent FDA approval