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.
volatility will settle and we will retrace a lot of yesterday's loss. yesterday was purely about Adam F. that is not a sustainable drawdown. I'm just sitting being patient. Overall mkt is getting killed today too. That isn't helping, but it's just one day. PVCT will trade on its own. Just wait till next week to see much higher prices. Adam F effect will wear off. Barron's used to have the same short effect on stocks and a few days later they were right back where they started.
mgmt has been working with the FDA for a long time, the break through therapy language didn't come out of nowhere. I think it is that or accelerated approval. either one and the stock is back to $6 very fast. good risk/reward right here.
this will go up. not many shares out there. half a million dollars in stock by a hedge fund is nothing to spark a tsunami. doesn't take much to squeeze it higher. I might add more today.
tonights trading prices will look ridiculous compared to tomorrow's high. I think we see some sort of epic spike. just like bitcoin prices themselves.
I bought another 20K shares. done for now. expect a huge day tomorrow. People will hear bitcoin on a low float stock and the sky will be the limit. I will be in no hurry to sell.