I dont believe in conspiracy theories but thought the board would love this. wall street is orchestrating a perfect symphony to give Q every opportunity before
The B launch. They believe the rems removal will happen soon and want to delay
B until Q gets stronger foothold. Thus no B launch will be forthcoming until FDA removes rems. What do you think?
The DEA and FDA are different agencies of the federal government and neither is influenced by Wall Street. This is another ARNA board myth perpetuated by people who believe in conspiracy theories. Not everything that happens in life (or to a stock/drug) is the product of corruption. Let me give you an example here. ARNA longs from before ADCOM-2 will remember that short HF holder Martin Shkreli tried to before the FDA to argue that Belviq should be turned down. The FDA did not allow him to speak. Two points here: If the FDA could be corrupted, why did Shkreli bother to ask to speak in public at the ADCOM, as he could have just acted behind the scenes and done his dirty work that way? And second, although he had a major stake in ARNA's failure, the drug was approved. So what does that tell you? I will say again, these arguments about conspiracy theories and corruption are so off the mark... They are from the same genre as those put out by Obama Birthers, Vaccine/Autism nuts, 9/11 Truthers, AIDS denialists, Grassy Knoll shooters, etc. Move on...
Read what Shkreil did when Mankind was up for approval. He was sending E-Mails to every FDA board member urging them to not approve Affrezza as he was short. Meantime the FDA chemist was placing his bets. By the way the chemist and his son are now in prison.
i dont believe in conspiracy theories. but i believe you are wrong about street influence and in particular shkreli. he, i believe, was one of the figures that played a big role in influencing the fda with its first rejection of B. it was only after huge public pressure which many of us applied that the fda approved the drug. so while i dont believe in conspiracies and it is unlikely the dea is holding this up because of street forces, it is naive to think that there arent individuals and lobbies that have significant influence on events in this country, including the approval of drugs. get real.
while i cant beleive fda would approve removal of rems i was shocked that they approved the drug with such limited rems. mm who is a favorite of members of this board has indicated that
the fda will remove the rems. i think this is what has the shorts hanging tough. they think the rems will be removed ant thsi will slow down any launch by B. in any event it looks like if it isnt the street that is preventing dea from moving forward, there is some force or inertia making this a very painful launch.
rems for vvus cannot be lifted by the fda...Vvus must do a cv study to prove to the fda that rems could be lifted...This talk of lifting rems is just fud toward arna...CV studies will cost vvus 200 million and will take years to compile info..Vvus just cant ask fda please change it for us or we will go bk....No lifting no changing until cv studies are complete....Bottom line...Plus eu is out of the question
They aren't asking for the REMS to be removed, they are asking for it to be modified so Qsymia can be sold in retail pharmacies. The physician training, data collection and reporting requirements etc will still be in place. Also, Vivus management said they expect the modification to be effective in 2H 2013. HOPEFULLY Belviq will,be launched before then.
i do believe in conspiracies. they happen all the time . two or more people working together for an outcome is a conspiracy. Its only a word and it has been skewed to be something bad . But there is a conspiracy to delay arna launch as long as possible and someone with long arms and lots of money wants that to happen. This is bs that it has taken this long to get this "sugar pill" as they say to market
Sentiment: Strong Buy
FDA a already approved Belviq so clearly the FDA felt is was safe and effective. It is the DEA and they are on schedule at this point. Much could be argued that they are taking to long, but with weather, budget cuts, meetings on capital hill about everything maybe they are a little busy. Or maybe they are just lazy and to the bare minimum to keep their jobs.
But the fact remains that we are going to get our final scheduling some time in the not so distant future and we will be on the market. Contact your senators if you want them to sit on someone, tell them that taking 9 months to get this done is a waste of tax payer money.
Interesting, but I wouldn't count anything out with these two products and the armies of investors on each side. Q has stumbled big time out of the gate and the powers to be in their camp are desperate to level the field at any cost. Certainly their move to shave the price in half is truly a panic move to acquire patients before B comes to market. These two products are completely different with Q being a concoction of two generics, and B being a completely new patented novel drug. If the FDA would remove the REMS for any reason on Q, it would surely signal a payoff of major proportions in money, jobs, or favors. I personally do not trust the FDA based on their corrupt past, and nothing will change my mind. We are just going to have to see how this plays out because the noose seems to be getting very tight around one of these necks. Expect the unexpected when there is so much money at stake. JMO
VVUS is no dropping its price. It converted its 2 weeks free promotion to 4 weeks for $75..The offer is not available to insurance providers Medco and CVS Caremark. This means income goes up overall from new customers, not down and committs them for a month
Easy as pie.... all V needs to do is remove the teratogen Topo component from Q and then the REMS could be lifted.... otherwise wait about 2-3 years to collect enough data to prove that it could be lifted.
Belviq and Q have nothing in common... the street doesn't know squat.