+ Watch ZGNX
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look out below
Here to mark the start of a possible pop.
Here I go, playing chicken with Zogenix with score leadership on the line. It's now three and a half months after the Zohydro PDUFA and still no word from the FDA. The company claims the FDA is finalizing a REMS but it's very hard for me to believe the FDA will go against an 11-2 negative Ad Comm vote based on safety concerns. Everything the FDA has done is recent months is consistent with a shift away from approval of any non-abuse deterrent opiate formulations. Feuerstein and PropThink are in the same frame of mind. Not bad company to be in.If the FDA does come out with a surprise Zohydro approval, this pick will immediately go down a hundred points but I'll welcome it, as it will create an excellent shorting opportunity. Approval is not synonymous with sales and I don't think Zohydro will make any kind of impact on the market for oral opiates. Between the abundance of cheap generics and a strict REMS, there's just too many better options. Sumavel revenue has been anemic with new partner Mallinckrodt and the company continues to burn 20M per quarter.I expect the company is praying for an unlikely Zohydro approval with enough of a sustained reaction in the stock to facilitate a large scale dilutive financing, which will buy them a few more quarters to come up with their next malfeasance. If they don't get that, they're likely to be looking down the barrel of bankruptcy.
drug approval chances are very high. full 2012 financial results to be announced Fri, 15th. Even if dont approved, price wont go down dramatically.
Pain killer approval
I was once a small proponent of this company, but the recent FDA decision seriously hinders Zogenix's market-beating potential, at least for the next year or so.
Hype of Zohydro will give this stock a healthy raise, but I don't see too many physicians prescribing a ridiculously addictive drug.
Great deal of insider buying. Good amount of institutional buying. Positive analyst ratings and price targets. They should be done with their public offerings, only up from here.
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