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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.
Acceptance of IR or ER signifies approval of pipeline, not the CRL. So far nothing has been approved. Hopefully by early next year that will change.
That is a ridiculous comment. They have virtually no debt as it has been all equity based. You need debt that can't be paid to declare bankruptcy unless you are suggesting they can't make payroll, but that is just as ridiculous. They hit a brick wall with the recent CRL. Will be interesting to see how they get around the obstacle.
You are spot on, but whether one or two beads, very similar physical makeup.
Funny, we were all told July 14th approval multiple times each day. We were also told SequestOx can't be defeated. We were told it would get oral approval. I think the board has had enough of this "due diligence".
Q4 2015 conference call, Nasrat stated in referencing Elite's tech:
"And what you do is measure it to what’s out there. Alpharma had the same exact technology we did, as a matter of fact, my former boss at Alpharma was in constant contract with Elite. In case, if Alpharma’s technology fails, he would have partnered with Elite. And that company was sold to King which were divested to Pfizer with one product for $1.2 billion, with one product in this technology. And now Pfizer is carrying on that technology and introducing products within that technology."
Nasrat himself stated - "same exact technology". Are we still trying to refute what the CEO has stated?
http://seekingalpha.com/article/3263515-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q4-2015-results-earnings-call-transcript?part=single
Tell that to Nasrat. He is the one that is claiming the technologies are very similar using his own words. Guess mgmt needs a chemistry 101 refresher according to you.
Hmmm. No submission means rejection, but a CRL from the FDA for SequestOx doesn't. Lol. Sure.
He is referring to the same technology and the characteristics of SequestOx.
Means absolutely nothing. "Good" is relative. It could mean they agree on a 3 year plan. It could mean SequestOx won't work, but they can submit the tech for ER. No one has any idea here until more is divulged at the next cc.
Here is what CEO stated in June cc:
"So, extracting Pfizer’s product with common solvent such as even water or any other product is really what you want done, okay? We don’t want something that’s so sequestered that doesn’t help you.
Now the issue becomes, how do you overcome people trying to abuse these products? There are ways you can, there are ways you can’t; this is why it’s abuse resistant not foolproof."
Notice he says using a common solvent such as water is wanted to extract the product. He also says there are ways the product can be abused. Let's not ignore FACTS the company has already communicated.
This could easily mean that it will only be a 2 year setback instead of 3. It is completely unknown until the company divulges further insight.
There is some truth to that - zero ADT protection for those who take drug orally at a substantially higher price point. Tell me why any reasonable doctor would go for that?
LOL. I'm calling BS.
"WORD is the meeting with the FDA went WELL!!"
Where do you see any facts that the meeting went well? There has been zero comment from the company on this. Stick to the facts.
CEO also stated that it can be defeated by some solvents or it would be too strong and wouldn't work.
Weezuhl provided great insight and his comments were discussed at length last week.
One point that I want to make is that just because Elite responded, does not mean they were acceptable to the FDA. Remember, the FDA can & did stop Elite. They determine what is acceptable or not.
Well, yes you are correct that it's not a label issue. The FDA calls it a safety issue that labeling alone cannot fix, which leads me to believe another trial is in order.
If SequestOx won't be approved near term & another study is required that may setback resubmission 7-8 months at best, I would welcome other pursuits. The trial execution will be done via 3rd party. We wouldn't want the company sitting on their laurels just waiting.
In all reality, I am expecting normal cc timing without Q&A. I think mgmt will run with assumption that this will buy them more time to deal with FDA. My two cents based on prior CRLs that I have seen.
Good thoughts, thanks for sharing. I personally think trust in mgmt has been severely shaken from extreme confidence that Nasrat has shown in all cc's including CRL update. I am intrigued at this point as to next steps since Nasrat does throw out a surprise or two every now & them.
Typical protocol is a 30 day waiting period, but others here claim they were meeting with them immediately after the CRL discussion. Regardless, investors simply don't have this insight and anything beyond what has been mentioned by CEO or FDA protocol is pure speculation.
No date has been announced yet. Will be announced late this week or early next. Will be interesting to see if we move forward with normal timing or wait to have cc until after having met with the FDA regarding SequestOx next steps. We may have normal cc in mid-Aug, but not accept any questions or those related to SequestOx until agreement is reached with FDA.
Good dialogue. I think it still remains #1 priority. I don't think we'll know more in Aug cc, as they will not have yet met with the FDA. Hopefully we find out next steps well before November cc. It would be ridiculous to wait that long regardless of other application submissions.
Yes, probably right. In the end, Elite has an obstacle and it comes down to whether the CEO can gather the troops and conquer. I am leaning towards yes, but not going to be easy.
Yep, as I stated - not 100% bioequivalent. Do the twist!
Naltrexone is scientifically known to not work with fentanyl. Not the same as other opiates. Here's one of many references that can be found. I believe other opiate blockers may work, but not naltrexone. Hope that helps.
https://treato.com/Fentanyl,Naltrexone/?a=s
Might be BS to the blind since he has already pulled one on investors by claiming bioequivalency of SequestOx back in 2014 when in reality it was NOT bioequivalent under all conditions. I remain skeptical as he clearly knew of this issue and mislead investors.