[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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Personally I think the market over reacted on Friday.
Lots of good things still to come.
AND Elite will still be meeting with the FDA about SequestOx.
Under Gottlieb labeling may yet be revisited because YES Virginia
the crisis is just that bad. NOBODY has anything close to an answer.... with the exception of Elite Pharmaceuticals. Maybe Lasers is right about this. I have no idea.
Disappointing Tmax results that can easily be rectified with labeling. Well golly gee imagine that!
As for the major Pharmas like Pfizer and Purdue..... they have ZERO
ADF products yet continue to pump out addictive opioids by the ton.....
with the exception of tamper resistant OxyContin. And what a joke that is. A $2.5 billion dollar opioid joke that can be abused quite easily. FDA has made it so that Purdue does not get the total piece of the pie for their formulation. Tamper resistant
just does not cut it anymore. FDA nixed Opana because it too was a joke easily abused. And Endo had the solution according to some who post here. Well, where is this solution now? Down the toilet, that's where.
So the bottom line here is what Elite has in their current pipeline
and what the FDA needs to do with the IR version of Elite's
ADF.
The onus is actually on the FDA. Squarely on their shoulders,
not on Elite's shoulders. Up until now Elite has done everything they could do. If Elite gets approval of this version with a labeling contingency until they can possibly reformulate again, I would say that is a distinct possibility. And if that reformulation fails then Elite has to carry the labeling forward
with what they have. It IS just that simple. No politics, just act and do the right thing. FDA has nothing to lose while buying time for possibly a better formulation for Tmax.
It is a no brainer.
The FDA will have to get creative if they want to truly curtail this epidemic Big Pharma has created and Big Pharma has no answer for. Mr. Gottlieb the ball is in your court. Deal now or wait years with no guarantee of an answer. Labeling revisited, or scrap everything with no IR solution.
I think the answer is very clear here.
Alfonso31, the FDA does have a choice here. They were willing to go with labeling before this whole fat heavy meal came into play, then did a 180 on Elite.
With enough time, and with monies coming in to cover the cost of further testing I believe Elite CAN reformulate and get acceptable
Tmax results. 1 hour and 12 minutes time average over comparator is not that big of a gap IMO.
Corpus, thank you. This is the way I see it. Under Califf Elite would still have to prove SequestOx Tmax results to be within
what they consider safe..... with no labeling to be considered.
Under Gottlieb maybe that will change. IMO it should with the contingency that Elite still continue to work on this formulation to get Tmax closer/better than the comparator otherwise SequestOx
carries labeling.
Lorie, explanation is simple. They knew I bought more shares right before 12 noon.
Then the Whammy. And that's my take on it.
Wonder what that guy that Nasrat sat down with during Valentine's Day said to him.
Not being confrontational Lasers, but if what you imply is true, that the data presented in the PR is from the original testing, my question would be where is the reformulated SequestOx data in the PR? Why wasn't it presented as reformulated versus original formulation?
That if what you imply is true... this PR it is poorly written IF your assumption is correct.
Don't think this to be the case though.
A one hour and 12 minute (average)(1.2 hours) more than the comparator.
Would be nice if you were right though. Maybe NH should do a mini
CC.
Yes. Agreed. It is gambling.
As providers we're facing unprecedented cuts across many states in the total morphine equivalents we can prescribe to patients with chronic severe pain; without suitable alternatives. And these cuts are solely due to abuse concerns. Seriously WTF FDA?
I understand the science failed us with regards to fixing the TMax issue, but the ADT formulation STILL WORKS.
To each his/her own. Trade, buy, sell, whatever.
This product is needed on the front lines by providers and patients.
--Nasrat Hakim
4 years before sentencing for stock fraud
Well Lorie, this company is not a one trick pony that is for sure, thank goodness.
And as I just posted to Lasers, SequestOx is not a goner by any stretch. We have a new guy in charge of the FDA. Let's see what he has to say about SequestOx when Elite meets with the FDA.
Good observation about the press release timing.
Fingers crossed.......
IMO there most definitely is FDA and $ELTP discussions to get Reformulated SequestOx ASAP without any further testing and monies.
But the PR most definitely does NOt give the statistics for the Reformulated SequestOx
NH lost lots more than either of us peons Couch.
Still not selling. After they meet with the FDA and get some guidance it will be up to the powers that be to decide what to do.... not any of us.
If this is as you say Lasers.... then this was one time to buy
and one heck of a head fake.
Thanks for your input.
Understood, but why would NH go on to say “We were hoping for better and more decisive results for the reformulated immediate release version of SequestOxTM”, said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We remain positive with respect to Elite’s abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months.”
Why could the PR not just state what the old results were and that the new BE results are being submitted to the FDA for review.
This PR makes no sense. Other top line results were released for other formulations such as OxyContin. In those PRs Elite came right out and said that the results were good.
Do you think NH is being super cautious not to say the reformulation is good or better than expected results because of past FDA decisions?
Otherwise this makes no sense. Why release any PR?
Don't have the transcript of the last CC but I thought I recalled NH stating that the results for Tmax were within FDA guidelines.
This is a poorly written PR IMO.
LOL! I could have waited and thought I made an outstanding buy at about noon. Could have doubled up on the amount I bought. That is the stock game though....... easy come easy go.
Just added a few Elite shares to my Roth account. Every little helps.
Yep. Sure appears that way. Patience. It's coming.
Put an order in for more shares. Not sure if it will come through, but if it doesn't I try again next week. It's a beautiful thing.
Like Paco Lopez riding Kelly Breen's Take Charge Paula,
or Joey Bravo in tomorrows stakes race, almost a sure thing.
Elite will just take patience. The perfect storm is getting closer
to fruition.
Nice Couch!
I've got over 1 million shares and counting.
Let's review other bold predictions
Correct.
long terms capital gains tax would dwarf that if I sold today
Track record on predictions made is a joke. Best to just wait and let it get pushed down.
You only have 3 1/2 hours today to finish your buying before Wednesday's news.
Yeah, just sit back and wait. Wait till the cows come home. Highly recommend waiting. That's the ticket.
LOL
Another prediction.........
oh boy.....
Gman24, it's coming. More and more states now running TV adds.
Chris Christie of New Jersey and now Tom Wolf of Pa.
Savvy investors don't pay tax on their trades
When the company is working on everything Elite is $3 million is nothing. Not a stretch at all when it comes to the R&D side.
Me too as the PPS goes lower
Just covering all bases in my opinion.
Tmax is within FDA specifications.
Elite has not even gotten their ER drugs out yet.
Even though a 24 hour oxycodone will require a 12-18 month phase trial how much money will that alone make?
Add to this an ER morphine with the same ER properties.
No other pharma has such a drug line that is also an ADF.
Also the standard 12 hour ER opioid ADFs.
It is coming... not a matter of if... just a matter of when.
Was on Hellgate tour of the Rogue River and met some folks at dinner that work in pharmaceuticals. Never heard of Elite until I told them. The opioid addiction problem is very bad out West as well.
Elite's ADF is going to be a game changer.
Took a long time for a come back....
Still not adequate. Try again.
Up to 21 cents today? But but but I thought 2 cents was coming.
LMMFAO!
Support at $0.20 resistance now at $0.24. Buying pressure continues.
Hmmmmmmm
sharpie you there?
Do you see anything to watch for Elite wise?
TIA
Looks as if Bollinger bands say the lower range is now $0.17.
If Elite breaks out this will be a nice run. All IMHO.
Good point Lasers and glad to have someone with contract experience
on this MB.
Nasrat seemed to be no fool at the shareholders meeting. Am sure he is doing his best and understands the situation perfectly.
Elite does sit in a position of strength where their technology is their strength. SequestOx gets approval and Elite's position becomes so much stronger.
Whateva........
These PRs are not fluff PRs. Nobody thought Elite would be ready
with BE data for this undisclosed SunGen drug this soon.
AND NOTICE! Elite did both a normal BE and a food uptake BE.
Elite is not screwing around anymore. No more excuses from the FDA.
No more "it's a labeling issue that can be addressed later".
And HOW would you prove it stockboy?
Wow off the charts illegal, unethical, and what ever else you want to call it bribery, collusion etc.