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And how many years was Amazon unprofitable?
Time to take the blinders off. There are so many levers that can be pulled here to manage cashflow appropriately. You do just realize they just signed a development partner to share in the costs of development. Sharing isn't defined as Elite owning 100% of the costs without any revenue benefit. Their manufacturing revenue continues to grow. As Elite develops their own pipeline it will only be icing on the cake.
Neither revenue nor profit pays the bills. Cash flow does. This is basic accounting. A company can be super profitable on paper, but without cash flow they become defunct.
The 8k that was filed yesterday, of course.
I believe Valeant received a similar letter a month ago or so for a Bausch & Laumb plant that has been running for years. It also was the reason of a CRL of a recent NDA. FDA must be cracking down on controls and forcing manufacturers to step up their game.
It is insinuated. We all know how well July 14th went down. LOL
And the stock price completely disagrees with that. If it was temporary, it would be built into the stock price. The PPS would be significantly higher than $0.17.
Please provide a link where a Type A has been accepted by the FDA. It was being requested. Doesn't mean the FDA will accept.
What documentation do you have to prove that? From same individual that said FDA can't stop us? Just curious.
They can present the July 14th date that was for sure a done deal. On slide 2 they could also quote,
No one will stop us. Not even the FDA."
Try listening again to the last 2 calls. They have been shifting the focus to take investors eyes off SequestOx. Plain as day.
Based on your quote used you are insinuating there may be another CRL for SequestOx and they will have to submit a 3rd NDA. Yikes! I certainly hope our fearless leader understands the action items clearly after the meeting of the minds. Didn't work before though when discussing ELI-200's BE studies. Perhaps this time will be different...
Because a CRL is clearly a good thing. Hahaha!
SequestOx was rejected. Nothing more needs to be said. But wait - CEO & CFO want to shift the focus to the amazing generics. LOL!!! 50% increase on nothing is still nothing.
I feel bad for those that believe all the rubbish here & trade on it. It is the creation of false hope.
You mean like the longer Tmax issues that SequestOx has compared to current IR products?
There will always be better & better tech created. If SequestOx is approved one day, the question then becomes what does Elite develop next before something better comes along in a couple years? If nothing better is created the entire pipeline except for measly generics get wiped out. There is no R&D being spent here. On the flip side, perhaps Elite will be big enough in a few years to acquire tech from others, but that is simply a pipe dream as the tech is currently at best on hold.
If FDA accepts Type A meeting. Don't forget the FDA can continue to stop them.
Many headlines show opiate revenue is declining significantly in that IR is given for a week and not refilled. Doctors are moving towards giving minimum opiate assistance to prevent addiction.
Type A is being requested. Still doesn't equate to approval or an agreed upon pathway.
A company can forever be in the "approvable letter" cycle by submission after submission signifying rejection. So please tell us, how much SequestOx can be sold with this "Approvable Letter"? Zilch, meaning: REJECTED until all SAFETY AND LABELING criteria are able to be met. As of today, Elite does NOT meat these standards. This can't be any simpler.
It is a rejection based on certain criteria being unmet. If certain stipulations are met, it can be re-reviewed and eventually approved, but it is currently in a rejected status.
The CRL was anything, but an acceptance letter. Approval is the only form of acceptance. Can't sell a drug without it. Until then, SequestOx is not approved, and until we know more, may not be.
And he most certainly wasn't overpaid for those generics. Lol. And how many are sitting idle worthless?
I am not questioning the payment back to Nasrat, but the timing of the payment in that ge delevered before SequestOx was approved - shareholders get ripped, but he is made whole.
In addition, it has been requested to prove another OTC company that has lent their company $1M unsecured. Done that. Case closed. It can quit being asked. Do you not think Nasrat has made his millions in paper with all the shares he has been given? It is quite evident that he has.
Logically, I can imagine loans from CEOs at tiny companies being rather common in private enterprise due to banks being extremely risk averse mixed with a CEO's typical clouded cocky attitude.
Yes, that is precisely what I meant.
I see that Endo had about $100M in annual revs for Percocet for years 2012 - 2014. Anyone have any rev figures from Teva/Watson/Actavis, Mallinkrodt, Mylan, Barr or any others that sell generic Percocet? I'm less interested in the total market than I am the smallest player in this crowded field of 10+ players already selling generic Perc.
Link must have copied wrong. Try this:
http://www.mmj.today/cen-biotech-ceo-funds-company-forgives-2-million-debt/
Isn't this Percocet that was just announced? It's why they filed the ANDA - for a generic.
OTC stocks aren't required to file SEC filings, but may do so at their convenience. Here is the article that referenced prior unsecured loans made to their company along with a $2M loan being forgiven.
http://fitxlong.com/category/cen-biotech-fitx-latest-information/
A simple internet search will reveal other companies whose CEO's made similar loans.
FITX is one such OTC stock example. Not only did their current CEO loan money, but also their prior CEO. Get this - UNSECURED with interest rates of 8-10%. Sound familiar. It should, but keep reading.
Their prior CEO FORGAVE $2M in loans made to the company. Now why wouldn't Nasrat do the same if he's so genuine & concerned about Elite? Oh yeah, he ensured he got his money back right before the CRL was issued. LOL.
Just goes to show CEO is mitigating risk. That's all. He doesn't forget this is an OTC stock, but some here do.
That loan doesn't exist anymore as it was paid back a few months ago with LPC funding.
Thanks. I will relisten later tonight. I think FDA may provide further direction at that point. Great to hear he clarified he is attempting Type A review.
How do you figure earlier than 2-3 years? ANDA review is at least around 15 months. Need marketing plan, gear up manufacturing, etc. I think that timeframe still stands. We still have zero insight regarding SequestOx pathway and per Nasrat, will be updated in the next cc (mid-Nov) so odds are highly against SequestOx moving forward near term.
Yep, this was the call he stated, "And uplisting to NASDAQ is on my mind and am planning for that in 2016".
Thanks - saved me a few minutes of searching tonight. Few months better than 10 years ago. Elite is stuffing their pipeline as quickly as possible.
Yep, primary purpose is to prove bioequivalency at same dosage levels as branded.
Anyone have latest median review time for ANDA? Last I saw was data from '07 nearing 19 months and on an increasing trend. Curious if median is now over 2 years.
We would have already seen the Form 4's filed. Nice try.