Lets say she really get to see the door, what happens... since she get kicked out b/c of approving a new Opiod (ZOHYDRO) so the new commissioner would never dare to introduce a new Opiod product (including Purdue's horse pill) ever.... still with me if you say yes... This would be a miracle for Zo is waiting as it would make Zohydro much more valuable, leaving the only and only option for those who can not take Acetaminophen anymore... also it will stop the addition of new players into the market completely. IMO this might work out as blessing in disguise for Zogenix
I agree what do you think specially in the scenario where people are asking her to step down because of lenient stance towards addictive pain killers do you think she would approve another double dose opioid? if Purdue's drug gets rejected... or the least gets CRLd then?
FDA said it could only be pulled when a better alternative is available which in this case will never hit the market.
There is silver lining in this that no other Opioid will enter the market ever... including MYL & Purdue and other big boys...and Zohydro remains in the market...
Blah Blah Blah Blah Blah any newbie should click your name and see what a service you have been doing for mankind Blah Blah Blah Blah Blah Blah Blah Blah Blah Blah Blah Blah
Really that's the best you could come up with, instead of laying low FDA will try approving another Opioid? and which is not the regular one but the most powerful opioid in the history of USA. Come on man just read before you post.... you think others are foolish.... if not now soon people will realize what is your agenda....
That's fine by us and it was good for you but why are you trying to help idiots like us? are you Mother Theresa or Gandhi or a shorty who is about to be grilled and I can already smell the charcoal? whoa ha ha ha ha ha
Even if she resign due to pressure, it will more good to Zogenix than Purdue as new Commissioner will never let Purdue's horse pill go forward....
"if large investors will sell off ZGNX stock in anticipation of that" they have not sold their positions though SP has come down drastically (close to 80% from 52 wk high), they are really quite no noise to change the Mgt or any other change (which I find it strange too) and increased their stake in the company then I thought what if they are TRAPPING the SHORTS for the biggest squeeze in Pharmaceutical history and buy the company for free and take it to private like Purdue imagine if that happens.... who ha ha ha ha
can you give me a reasonable answer why they have not reduced their position so far or intervened yet as they hold majority stake why?
Or if this stock goes up then DRD369 will loose his shirt, paints, underwear and everything else he owns (he is taken a short position- please click his name and see what he has been upto) as it has close to 20 plus % of short interest and 81% institutional holding and 60 plus cents/ shr (todays closing price 1.19) cash and no debt and 1 FDA approved drug and 1 FDA approved device (licensed to Endo Pharma but still owns patent & manufacturing), another sNDA to be filed in a week or so for Abuse Deterrent version of their already approved product.
The stock has been beaten down in last 7 months or and currently selling at a hefty 80% discount from it 52wk high. Before investing do your own DD (you can find tons of article and controversies around the company, IMO most are just propaganda to keep the new entrant/ drug on check as it is a multi-billion (above 15) dollar market captured by very few big players ( and Zohydro is the only Acetaminophen free Hydrocodone tablet available in the market right now) but do not listen to Drd369. GTY
But there is no substitute available for Zohydro, Purdue's drug is double dosed 24hr 120 mg horse pill, Zohydro (30mg- 85% of total sales) is a 12 hr. Extended release there is no comparison here.... if there was one FDA would have never process the review of Purdue's drug PDUFA as it has already given Zogenix a 3 yr exclusivity till 2016 (so the two products are different). Guess you also didn't do your DD well too. Who Ha Ha Ha Ha
You can not be more clear than this that Zohydro cater certain need of drug and can not be singled out for potential abuse. and plainly mentioned the main culprits -(excerpt from FDA commissioner's article) "To reduce the abuse of products such as Vicodin, the Drug Enforcement Administration followed FDA's recommendation to restrict prescriptions of hydrocodone combination products." Keeping everybody in check not only the poor little guy.
FDA is neither in pressure nor in a hurry to approve any opioid, example FDA commissioner's recent article (published yesterday) which clearly depicts that FDA has no remorse approving Zohydro as it meets an unmet need for a drug which is Acetaminophen free. On the other hand Purdue's horse pill is just a very potent version of Zohydro with AD, also Purdue has a proven track record of falsify and mis-market their drug so FDA will take its time before saying yes or NO.
Blah Blah Blah No FDA is never feels in a hurry to approve a drug except in case of a vaccine needed for an epidemic or a breakout so stop spreading white lies..... Blah Blah Blah
Do you have any real example where FDA rushed and approved a (life saving) drug in 6 months... no lies or your usual BS... give us a straight answer with the name of the drug and exact facts please...