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So is heroin on the street corner except it is probably sold with a better margin then Elite can capture.
Very much akin to my children entering the multi multi billion beverage industry with their lemonade stand. Look at the IMS market we are in! Wow!
I think they have a Trimipramine competitor. There goes our profit.
Haha! That made my day.
Thanks for the update. This is news to me.
Wait, how many times was it mentioned that Puracap is our preferred partner since they own the Chinese opiate market. Strategy here is just like at Elite - being blown like dust in the wind and the flip-flopping of politicians. Today's news is a nonevent.
This is probably a simple amendment excluding immediate release tech & giving SunGen more of the profits since Elite's tech still has yet to be approved by FDA. LOL
For what? There was no visible change. Notice the IMS is the exact same that has been quoted many times. Using IMS data is a joke - you need to know the market potential for their product alone. It isn't IMS for sure. Just normal bloated speak.
Since IR tech failed, management needs to show something, but nothing was new here other than a little more insight into the market segments. Hilarious.
Now think about this - why would the FDA have Elite go through all the rigamarole that they have since late 2015 since the CRL (article misstated year) if all this was a labeling issue? Elite didn't even get an Adcom to discuss labeling. That ship has sailed.
Then you need to learn to read financials. Revenue has consistently decreased over the last several quarters.
Only if ER fails with an approval will that be the case.
Neither is any decent FDA approval...unless you are counting Trimipramine. LOLOLOL
If ER doesn't get approved this will go to 0.02 for sure. Who knows what else management is hiding after Tmax surprise.
Very true. Sadly, much of that historic speculation has turned out to be true of SequestOx and management's capability.
Crazy to think that SequestOx being an IR candidate had Tmax that falls into the normal realm of ER. Hmmmm....
No.
No.
And No.
Anything else is speculation.
Hmmm...makes zero sense why they would want big hero Elite to continue with the study. My guess is there is much more to the tech that we haven't seen raising eyebrows.
"Nothing will stop us" says the CEO...except for the FDA & their own trial results, of course.
Claw backs are extremely rare on comp. In the US, boards have the mentality of "I'll scratch your back if you scratch mine." Nothing will come out of this.
C'mon Lasers. Why would Elite make any additional data public? They have provided minimal data to say the least and have cherry picked certain highlights for PRs.
They hire out professionals to perform the statistical analysis. Granular details on the study is not going to be made public. "Not gonna do it."
I like the clarification of the ANDA filing, the same "this quarter" wording was used as it was during the time of the conference call that fell during the prior quarter. He just bought himself 3 more months.
Perhaps it should be rephrased as questions for wannabe amateur management.
Not clear = fail
You clearly don't understand what results the company was seeking. Here is a big hint:
Why is the company stopping the pursuit of SequestOx? They have much greater insights than we do. You don't stop a program if it met the primary endpoints. The reformulation caused even more issues than the original. This is plain as day.
Even then, the results didn't meet the primary endpoint. They were worse than expected. Path forward is shut down.
But the Tmax was high on the original formulation. You don't want similar. You want better. It is clearly not what the results show.
Already done.
Just like "no one will stop us". Not a chance here either.
Dead wrong. This is a situation of last resort. Nasrat is only waiting for final confirmation that SequestOx is dead. This is why it is "paused".
ER ADT's & SunGen will need to be the saving grace, but SequestOx is no more.
His damage control is hiding under a rock during each cc by not having live dialogue. Amateur at best.
Why would FDA chief need to be reasonable if the results are so good? The results were crap. If the study shows Tmax is high under fed conditions, guess what? IT ISN'T BIOEQUIVALENT. Basic issue that will not be resolved.
NASDAQ - per your private note below, if they had faith in the other two options they would have planned for a Plan B with the FDA. This is just a continuation of the same ridiculous game, nothing more than false hope & hype.
"hey also have 2 other formulas that reduce fed Tmax.
It's not over till it's over.
How much of the $2.5 billion dollar market will a Elite steal
With the only generic ADF OxyContin?
Patients have been waiting patiently for a generic for many years.
The savings for patients and insurance co.s will be immense.
I'm heading to the beach for a Bon fire, talk more latter.
GLTY"
Just another way to string investors along. FDA doesn't even need to issue another CRL. Elite just hung themselves out to dry.
Wishful thinking at best
Funny. Elite's PR states the results were garbage. Why do you suggest otherwise?
ER is minuscule. Company won't be sold for $2-4 as some here say. That would have been on the high side with SequestOx, but extremely unlikely now. Now it is just junk with uncertainty.
Works with the exception of the Tmax. LOL If labeling could solve Tmax the FDA wouldn't have given it a CRL and would have given Elite an Adcom to discuss labeling. Clearly didn't happen.
Never going to hit the 0.20's again, then teens. Just fell below 0.10! This is reality. Market just baked in FACTS into the price instead of "hope".
Hope that Eugene brings value, hope that SequestOx was BE, hope that Elite would own the ADT IR space - is all now just pure fiction. It always has been.
SequestOx FAILED!!! SequestOx failed multiple times. It is no good. Inning is over. Move on.
Hope for that is a joke. It just got denied twice. This time for good.
The BE fed study was completed. Those are the failed results. The dosing study was paused since the results showed it wasn't worth continuing the program.