incorrect...obviously you are not a lawyer. judge is just giving MA one week to comply with ruling. MA has one week to completely lift the ban or they are in violation of the order. this is a permanent lifting of the ban come next week.
my guess is you are with the company posting here. You created your yahoo ID the same day you posted and you chose to make your ID "generator driver" . I doubt this is an independent post.
QCOR getting bought out today. All the attacks on the stock the last two years drove it down to the low 20's. They just kept selling their drug and being smart as a mgmt team and now getting bought out for over $80/share today. If Zogenix can thwart most of these bans/legislation (which is what is happening (no FDA, HHS or Congressional ban seems at all possible)), then Zogenix will more than recover. It will just continue to climb over time. BTW, I bought QCOR in the mid 20's on the "threats", but sold in the mid 30's. I just didn't have the conviction to ride it out unfortunately. I do on Zogenix though. I won't be selling for a long time.
He is a big reason i am invested here. he was a big part of driving WWE to greater viewership. He has a lot of strong connections to get content put on this platform. The McMahons might do some goofy acting on TV, but they are very media savvy and that's why they are billionaires. Today's Miramax deal is just like the type of deals Netflix did to get on top. And China is over 4 times larger of a market.
GALT came out with news on their treatment. I read the whole report. Honestly, it is tremendous data for just 4 small doses. ICPT should buy them now. I know what I'm talking about here. GALT has something that works on NASH. There is a conf call about it early in the morning.
I sent that article to Briefing in Play where I am a subscriber. Hopefully they post it. that would definitely get a lot of peoples' attention. Please keep up the fight people. We need the Senator exposed and we need the truth out on Zohydro. Contact your attorney general too please.
AWESOME! I really believe the biggest reason that article was written was the efforts of a lot of people on this board. Please do not stop with the efforts! This article is great because it contains FACTS. Unlike the other stuff that was written against zohydro. Please link this article and send to your senator, rep AND attorney general. Post it elsewhere too. We are in a fight people. Also, send it to any senator or rep that you see supporting once of these #$%$ bills to remove Zohydro. let's put some serious pressure on them than they don't want to be tied in with supporting this foolish legislation or linked with Senator Manchin! There is power in numbers and that's why we saw this article written. Post it on twitter too if you have an account to someone with a lot of followers in this space.
every single author of every article with misinformation. I'm telling you people, you need to fight back with the truth or these politicians will get us. Make these authors retract this BS they have been writing. this negative media and politicians are hurting the value of Zohydro and thus your stock. Fight or get beaten. That's what I have to say. I have made dozens of calls and sent dozens of emails. Everyone here needs to do it though if you want to be on Zohydro's side.
Also, have you already prescribed it? Do you see other pain docs readily prescribing it? What % of patients in a pain clinic do you see using it?
Curious, do you have to increase the hydro dosage to make up for the lost acetaminophen? i've been reading some pain discussion boards and it seems like something that needs to be done. equal dosage of hydro from say Vicodin to Zohydro (accounting for the ER though) still leaves a gap that acetaminophen was covering. so answer is probably a little more hydro. I'm curious if that is how you handled it with the patient requesting the Vicodin to Zohydro switch? Also, has a Zohydro rep visited you yet? Are other pain docs as aware of Zohydro as you are?
It will be an interesting landscape the next few years, but people will be disappointed if they expect Zohydro to be removed from market. Purdue will continue their lobbying efforts though to exact political pressure on the FDA to change the law and allow their ADT formula on the mkt. I can't guarantee the outcome of that, but ZGNX is not in the bad position these articles are portraying it to be. Stock might head a little lower short term, might not. But I see 5's again in a few months.
yes, and that's why they get the "short" 3 year exclusivity and not longer. all agreed upon with FDA and Zogenix prior to filing. Zohydro has 3 year exclusivity on single entity hydro and that includes ADT or not. Unless FDA changes its agreement here and that is without precendent and would only mean FDA caved to political pressure and changed their own law. Fyi, I have verified this fact with ZGNX management recently believe it or not.
pretty much. FDA has to change its own law to let Purdues drug (even with ADT formulation) be marketed before Oct 25, 2016. Will FDA do that? They haven't bowed to pressure so far esp. in approving Zohydro. Even if they change their 3 year law, that does not mean Zohydro will be pulled and quite frankly, it won't be unless they violate the REMS and safe use agreements. FDA will let Zogenix have reasonable time to come up with their own ADT and Purdue won't get exclusivity on the ADT formulation like portly says. that's not how it works.
Portly, this is what I do for a living. I know the rule on 505b2's and what it constitues in this particular case. you are incorrect in your interpretation. call Roger Hawley and ask him yourself.
not true portly. zohydro has 3 year exclusivity for all single entity hydro. ADT or not. I am not here to do everyone's homework for them, but what I'm saying is a verifiable fact. Purdue knows this too, but they are trying to keep the political storm going so when their drug is ready they don't have to wait till the 3 years is up. But right now, that is the FDA law and it would have to be changed to allow Purdue drug on market. And even if it is, that doesn't mean Zohydro would be pulled if the safe use stuff was followed well up to that point. complicated issue that I don't have all day to write about. bottom line, ZGNX is a buy in low 3's and won't be seeing any competition soon.
means a lot of things...but for one, read "an abuse-deterrent formulation that remains safe and effective for patients". that is a key phrase here and implies not just because they came up with one. Endo pharma knows exactly what this means. no one should be expecting zohydro to be removed from the market because it won't be.
that gives Zogenix time to get ADT formula out there without competition. Zohydro was given 3 year single entity hydrocodone exclusivity by FDA on approval. Does anyone ever do their homework??? FDA follows its laws. Purdue has to wait. Purdue is trying to play the political game though. So far it hasn't worked.
jb, any feedback from your doc on the number of patients he has that are converting this month to Zohydro? Or even the % of patients he has that he thinks will convert?
Daddy, I'd be interested in knowing whether your pharamacist is seeing other prescriptions for Zohydro besides yours. The uptake of Zohydro will determine how high the stock gets near term. If you are back in there soon, please ask and report back. thanks!
Zohydro is a black boxed drug. FDA does not allow PR announcing launch of black boxed drugs to general public. Would be considered "promotional". But look for them to confirm on the earnings release on Wednesday that zohydro is launched. that way it is not a general PR, but one directed at investors. those here calling for CEO to get out there and defend Zohydro don't understand the rules the company has to follow. I'm sure they would love to, but it is absolutely not allowed. And those looking to slam Zohydro know that the company can't defend itself right now.
The negative media will subside and news of product uptake will drip out. I'm long because I think this can get to $500M in sales with just marketing to certain chronic pain patients and that is a multi billion dollar valuation for ZGNX. There is demand for this product. Guys like jbcooper can confirm that. ER formulation is attractive too and not just the no acetaminophen. Taking twice daily is much better than 4+ times a day. this is just one more storm to ride towards a much higher price. I will be riding out storms for some time until we get to a much higher valuation that I think is inevitable.