[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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Elite already has Destiny....
It will be named Mydixaphloppin. They are also working on a drug to turn lesbians straight again..... Gottdicaggain.
There are plenty of drugs out there that have been root causes of current epidemics, death, and abuse; yet the FDA let them skate. OxyContin poses a far greater threat, yet that formulation was not held to that same standard as SequestOx. I call that a double standard.
They would not waste the time and money on this trial if at any stage of the trial this drug did not show something. Just as with Dr Paterson's U of Penn who led the development and testing of a cancer vaccine that uses the common bacterium Listeria monocytogenes. She would not have pursued this had there not been positive results.
With the "wildcard" isradipine there may be a slight bump in share price should the study prove positive. I tend to think that there will be a bumpback up to $0.20-$0.25. Agree with others that overall it will be revenues over time with isradipine that will contribute to the share price movement. Demand for this drug will dictate that.
Granted labeling for use of isradipine for P D patients will be another step. Will the FDA grant off label use in the meantime?
And while only Teva and Elite manufacture isradipine currently, there will be other pharmaceuticals jumping in. Gaining market share will be very important during the first couple of quarters IF this drug is found to be
critical in delaying and helping those with P D.
So this "wildcard" may be a temporary jolt in revenues while Elite/SunGen's other ANDAs come to market.
As in the last CC NH tempered his expectation of Isradipine and the impact potential it could have on Elite.
The FDA should have nothing whatsoever to do with anything. As you yourself have stated word has pretty much been mum with regard to this drug and its potential use for PD. Study results will be out in early May.
N2K has an expertise in this area. This is a part of his bread and butter.
Highly doubt anything has been said about anything with regard to study results. And having said that results are pretty much under lock and key until early May how would anyone be privy to results?
The only guilt association here is that NH did say the company has been receiving calls from PD patients. That the company is not a pharmacy and cannot sell to the public. If this admission is supposed to provide any sort of tell as to study results please provide it. Otherwise it is just being honest about PD folks calling Elite when study results are still to be determined.
More like it is highly unlikely Elite gets a CRL for the pending CNS drugs in the cue due to the fact that the facility just had their 3rd FDA inspection in a short amount of time. No observations.
The FDA is fickle these days. Regulations are NOT that strict because this administration wants cheaper drug prices. Also may be the reason Gottleib is stepping down..... frustrated Scotty.
Pay for play.
Why would anyone drive to a cul de sac in North Vale NJ?
Maybe you were looking at the wrong parking lot. Is the bike shop still there?
Doesn't add up.
Who will make the drug cheaper? I'm betting on Elite/SunGen. Teva will also mark their drug up due to their name.
It's getting hot in here.
May will soon be here. All will be told then. Elite and Teva, only two currently making this drug. Place your bets.
Still does not cite how the mechanism may or may not work in a neuroprotective way. This is total conjecture on a mouse model.
Where are the mice in a phase III NIH study? Not there, only humans.
Cite where this tells the reader exactly how the mechanism works. It does not because they do not know. It is pure conjecture based on what "they" think is happening, not what really IS happening.
NEXT!
Cite the literature that conveys the mechanisms that reduce the tremors in PD patients. Is it something in the way Isradipine works to block calcium or is it something else in Isradipines chemical structure that works on PD patients? That's right, cite the literature that discusses the way in which Isradipine may work to help PD patients.
There is no such literature... yet. Until May and even after, there will be theory and conjecture, but more than likely nothing concrete. Same as with T cells and the body's immune system. Wild guesses from fantastic egocentric Docs, until Dr Allison, a nobody figured it out without that Harvard medical degree.
May 29th March 29th April 1st May 1st... why not just quote the whole damn calendar?
When they come they will come. Geesus H~!
What some should really try to understand here is that not any calcium channel blocker may work for Parkinson Disease. That there may be something in the way this particular CCB, Isradipine, works to reduce the symptoms of PD and prolong the lives of those with the disease.
Will have to wait for the findings in May. Just something to keep in mind.
Naaaah didn't overlook anything. Glad I could help.
You expect Elite to make billions of dollars? Excellent....
And if Isradipine does turn out to be a positive treatment for folks with Parkinson as was mentioned sales will drive the stock price up. Sales cannot happen overnight, but demand can make sales and revenue grow at a rapid pace. Then there are the CNS drugs to come on line.
All in all, could be a nice rise in revenues in a relatively short period of time. Have seen it at my place where in one quarter demand drives the revenue made way UP.
I second that JGD~!
LMMFAO!!!
Never seen a bullshit meter pegged like that one~! LOL!
Thank you for your take on it. Very good observations IMO.
PH4RM4C3UT1C4LS wgat is your take on Lannett? My take is this, been surviving since 1942, and must have made valuable, reliable contacts since then. Good choice IMO.
My turn may be coming soon. Could not have timed it better.
Nope not even close Doc. Elite will be making more revenue than Purdue very soon, heck maybe even now~! LMAO~! So damn funny~!
Purdue ~2000 lawsuits~! Ahhhhahahahaha~!
There is reason for this push back down again. Just my opinion and my experience talking here.
Well, the FDA does have it's head up its ass at times. And for that reason many drugs not approved in the US are approved in the EU first.
Instead of saving lives the FDA often impedes the process to the point where lives are lost. Some watchdog agency... eh?
Lannett is growing. They have a facility in Philly.
This agreement was a joint agreement Elite and SunGen both agreed to.
Lannett must have something or they would not have entered into it.
Annual awards.... like S&H Green Stamps? Just kidding.... hope it is something very good.
Thought this vote was just to increase shares available.
$280 million in revenue/850 million shares OS (over what it is) = $0.33/share x PE 17
$0.33/share x PE 20
And don't forget a nice PE ratio of 17 or above in any earnings per share.
Just don't go by what you get now. Elite is not in a full blown revenue growth stage just yet. When Elite starts to generate REAL revenue there will be serious attention paid to this company and the potential here.
Potential is a key word. PE ratio will begin to be factored in at some point and as JustGoDeep pointed out it could be quite substantial. Not necessarily warranted, but PE ratio could be quite substantial.
My PE ratio of 17-20 is conservative and I will stick to an eventual PE of 20. That will be good enough IMO.
Man, sometimes I wish Lasars was still here to see this. Would have loved to get his take.
Well, gotta say good work Gman and Ama. Something to ponder as we await who it could be for the CNS drugs.
I know this is between Elite SunGen and the sales marketing partner, but does anyone have any idea of what the nominal fee is for sales and marketing? Glenmark with methadone and isradipine. Whoever it turns out to be with the CNS drugs.
Ball park it percentage wise. Thanks
NASDAQ, been going through some calculations and Isradipine could be a bigger than thought revenue maker for Elite. If Isradipine comes to be, Glenmark will take a slice, but that is it. Teva will compete, but Elite will be right there too.
CNS drugs like Adderall IR and going with a sales/marketing company that specialize in CNS drugs. Split will more than likely be 3 ways, SunGen and the larger reach than Glenmark company.
Current revenues added onto the mix.
With just this I think Elite will surprise. The addition of an ANDA approval for the $1.6 billion market CNS will be another revenue raiser.
Going to be very interesting buddy...… BTW, thanks for the PM.
Sackler family to lose it's money cow? Oh, I forgot about the Sackler's backup, Mundipharma. Now they can sell OxyContin to countries with no protections in place. So sad.....
but but but I thought Purdue had the formulation, OxyContin. And Purdue
has a lot to do with Elite. The FACT that Purdue did not acquire Elite back in the day is hysterically funny. They had the chance... now look at them. Pathetic! LOL LOL LOL
So even with Elite's revenue intake today, seems likely they will be bringing in more than Purdue. So funny!