1. SSRIs - This class of drugs has proven safer, just as effective, and 1/100th (according to Ray) cheaper than your generic boutique mixture of cough syrup and heart anti-arrhythmia medicine.
2. PBA is extremely rare. Very few individuals have this affliction let alone sufferers that need medicinal intervention. As we have seen over the last couple of years very few people have PBA...I mean really...how many times have you ever seen or known anybody with uncontrollable laughing or crying? (besides the lying carney barker with all of his family members)? Probably as many times as you have seen the sasquatch.
3. Physicians know exactly what PBA is, how rare it is, how it can be mitigated with cheaper, safer, and just as effective SSRIs, and counseling. Saying we need more education and publicity about PBA is a farce and a joke to any doctor.
4. The LTC setting is a double-edged sword. There may be a statistically larger population that have PBA(although still rare) however they are also taking multiple drugs that could and probably would interact unfavorably with Nuedexta. Old people in nursing homes take a lot of medicine and eat a lot of grapefruit (look it up). BAD NEWS.
5. Most people that exhibit PBA symptoms actually have depression so the obvious treatment would be with a SSRI to treat the depression - if they happen to only have PBA then great news...the SSRI treats that effectively also. Nuedexta will not help nor treat depression so any good neurologist will start with a TCI or SSRI and then 2nd or 3rd line move to Nuedexta.
6. Prescribing Nuedexta to any person with any kind of cardiac history or chance of cardiac history requires the physician to do a baseline ECG then an ECG 4hrs after dosing with Nuedexta to see if there are any cardiac arrhythmia issues. Are you kidding me? Think how many people in the LTC setting have cardiac issues - blow it off? Sure that would be a good bet for a medical malpractice suit since AVNR themselves recommend the ECG precaution - can you say HASSLE - just prescribe the SSRI and take care of the issue.
7. AVNR is pursuing indications for Dex/Quin that don't make sense. Ray has expounded on these much more effectively than I could - there is just no empirical data that would support this magical concoction of cough syrup and quinidine will work for anything other than PBA (and barely better than placebo) or a nasty cough. Quit smoking your hopium.
Good Luck...You will need it.
Sentiment: Strong Sell
You're such a moron you don't realize that the above post you keep bumping up makes MY case, not yours! You say "I mean really...how many times have you ever seen or known anybody with uncontrollable laughing or crying?" It is everywhere in head injuries and dementia's and stroke and CNS disease.....Keep bumping your stupidity and Phack Off
Sentiment: Strong Buy
I'm getting more and more skeptical of EU approval...I just can't believe with the danger of quinidine and how it barely beat out a placebo they would approve N - especially with safe, effective, low cost generic SSRI alternatives. Just my 2 cents.
Sentiment: Strong Sell
The EU has to think about the patients with PBA who don't respond to SSRIs.
My opinion is Nuedexta is not so dangerous that it should not be available to them.
Approving a drug doesn't mean it is absolutely safe. It just means that there are some clinical situations where the drug should be used and physician/patient teams can be trusted to use their judgement in weighing the risks and the benefits.
Anybody else think AVNR is going to tank below $2? I think there is a good chance N gets rejected by the EU due to the danger of Quinidine. Any thoughts on this? Mr. Winkles? Ray? Carney?
Rimchimp (oooh oooh ahhh ahhh)
Sentiment: Strong Sell
$2/share is still a market cap of about $275 million which isn't too bad for a company with a run rate of net revenue of only $60 million.
I don't think the price will go below $2 unless there is an unfavorable patent decision which I think is expected in December or unless there is some negative publicity because of sudden cardiac deaths.
The drug is still not being used by enough people to see the thankfully rare events of torsades de pointes due to the prolonged QT interval or even to see much of sudden cardiac death that occurs unrelated to being on a drug that prolongs the QT interval. So I think we are unlikely to see Nuedexta blamed fairly or even unfairly for sudden cardiac death at this low level of use.
As for European approval, I think the EU will approve Nuedexta. Approval just means the drug can be made available for physicians and patients to make the decision as to whether the risk outweighs the benefit.
Not to approve the drug means it is so dangerous that someone with severe PBA who does not respond to SSRIs or tricyclics or who can't take SSRIs or tricyclics for other medical reasons can not have their physician even consider the option of dex/quin, except through a compound pharmacy.
I don't think dex/quin is so dangerous that it can not be a part of the armamentarium against PBA. What pricing it gets is another story. Also how much use it gets, as we have seen in the United States is yet another story.
Especially in a more cost-conscious system like the EU.
So I think European regulators will approve it. Thinking about whether they approve it just for MS and ALS or if they give it the same broad label for all of PBA that the FDA gave it, I assume European physicians who want to use dex/quin for PBA will use it , regardless of the underlying neurologic condition.
As a matter of good form I could easily see the EU approve the drug only for PBA in MS and ALS patients because those are the only populations that were studied.
Why Avanir did not put other neurologic patients in their study, at least stroke and Parkinson's patients and traumatic brain injury patients, is beyond me.
But I think European regulators would only give the limited label (only ALS and MS patients) if it is doable for European physicians to prescribe dex/quin "off-label" for PBA patients with other underlying neurologic illnesses because I'm sure the European regulators don't want to deny patients with severe PBA a potentially helpful treatment.
ray's still going to push those cheap "safe" SSRI's. He's still waiting for that first
Nuedexta induced heart attack. The EU is looking at N's US track record and
will make the right decision. When they Google SSRI, they will see many horror
I think AVNR will revisit sub $2 per share. Just my opinion based on the above observations. Anybody here think the price will go up...say up to maybe...um....$250 per share?
Sentiment: Strong Sell
I expected PINOCCHIO TS to jump up to the plate with $250 a share since that was his call back when the stock was over $5 and he was telling posters here to double down with both fists, hold your nose, going in head first. I do not think that he knew how deep the bottom of the pool was for AVNR. He just threw away the money on it.
Exacly my point ealier. The longs here think the can say whatever they want yet they continuously lose money. There is no doubt in my mind that this current pps is 30% higher than it should be. The company has lost $130,000,000 in the last 2 years. With less than $70 mil left, they will have to dilute shares to stay in business. At best a buyout will bring $5.00. EU approval is not going to be the factor that these longs claim because the pricing will be far less than the US. Let these longs keep yappin. They will not see $12 pps as they claim ever!
Your item 4 could be wrong Rim. Grapefruit causes problem with blood thinners like Warfarin. A lot of old people, and young people like me, take blood thinners. The rest of the stuff is considerable.
It's good to see you here again dude. I have shares again with a cost basis of $2.80 after exercising my $2.50 Jan Calls.
Hey, i did not listen to myself at $3.25 to sell and buy back in the $2s earlier this month. That was a mistake I bet. Option X and the stock is at $3. I bet it head fakes and goes lower. I will add in the $2.70s if I am lucky enough for it to get there later this month. Are you looking to get in at a point or does your title say it all? I think the values are a little low but what do I know? You are the trader.
Cool that you are back. We have been dealing with Homos and stuff here for entertainment. I had to put a bunch of freaks on ignore with GreatDayForLosses, which I have never done before. I kept Traderpuke because I like to know what AVNR will blow up tomorrow. It is for my own mortal protection.
Mikie is here. He posted me. He is trading around his core position. That is cool.
Hi SS - great to see you. I'm not buying till it is below $2. Call me stubborn. Hey I was curious if you believe in sasquatch and if you had any first hand experience with either sasquatch or PBA? It is too bad the loony bin took over this forum. Used to be fun...now it is just that punk timsmith, jipper, cabodogge, johnnysmoke, smitytaco (all one person) and 3 footers and that dork otc/wekill stinking up this forum. I see now that I have moved on the carney barker has somewhat vanished. Good. Probably on another fake vacation to the Swiss Alps. #$%$).
Sentiment: Strong Sell