I don't believe NCE/NME status has played a significant role in Qsymia's launch, but notice that Vivus launched the drug on its own. No Big Pharma partner. Amarin doesn't have a partner either -- yet.
Synds: "Has MannKind (MNKD) found its bottom?"
I don't call stock bottoms. The most positive thing I can say about MannKind is the recent financings give the company enough cash to fund operations through the end of the Afrezza phase III trials expected mid-2013, perhaps longer.
Taking a step back from the fiscal cliff doesn't seem like sufficient reason to own MannKind but you may disagree. Fundamentally, MannKind is still a mess. The balance sheet is a travesty, with close to 380 million fully diluted shares outstanding, $128 million in debt and a $215 million in open convertible notes. The company continues to survive only due to the irrational largesse of founder Al Mann. No partner has stepped forward to legitimize Afrezza, probably because Mann is the only person who believes diabetics need or want an inhaled insulin device.I understand there may be trading opportunities in MannKind, especially as we get closer to Afrezza's data release in mid-2013, but don't overlook the enormous regulatory, commercial and financial challenges still in the company's path. NK writes: "I am interested in Orexigen Therapeutics (OREX)." I'm interested in Orexigen, too, because Contrave might just be the Goldilocks of weight-loss pills. Goldilocks picks up the big red bowl of porridge (Qsymia) that belongs to Papa Bear (Vivus) but it's much too hot to eat. Goldilocks then picks up the blue bowl of porridge (Belviq) that belongs to Mama Bear ( Arena Pharmaceuticals (ARNA)), but it's too cold. Finally, Goldilocks finds a yellow bowl of porridge (Contrave) that belongs to Baby Bear (Orexigen.) She tastes the porridge, and it's just right. Not too hot, not too cold. It's delicious, and she eats the entire bowl. Chris asks: "Do you think Isis Pharmaceuticals (ISIS) can get CHMP approval for Kynamro?" Yes, I can see European regulators approving Kynamro (mipomersen) but, like in the U.S., only for the narrow homozygous familial hypercholesterolemia (HoFH) patient population. Efforts to expand Kynamro's label to treat a broader (and less fatal) forms of high cholesterol is going to be very challenging given the drug's safety issues. Alex: "What do you think about Osiris Therapeutics (OSIR)? Earnings next week!" Prochymal was approved for sale by Canadian regulators in May. Will Osiris ever get around to launching the drug or generating revenue? I won't hold my breath. More likely, Osiris CEO Randy Mills will use next week's conference call to blow more smoke. Remember, Mills works for Peter Friedli and his Swiss investor friends. Several readers on Tuesday's live chat asked about Dyax (DYAX) and Exact Sciences (EXAS). Answers next week, I promise! -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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