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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.
I did answer it. He profits off the premium in selling to Elite. He isn't going to buy a product & sell to us for the same price or a discount. There is additional benefit to him.
Let me ask you this. Why would Mikah be involved in a transaction from Teva? By going this route Elite has to purchase the rights in some fashion from Mikah (at a premium) making Nasrat the sole benefactor immediately while also benefitting from long term benefits earned through Elite. This was not in the best interest for Elite, but rather the CEO. I am all ears if anyone has any insight why Mikah was involved. I love a good dialogue, but as of now I see greed & slime.
Just lining pockets and executing Plan B, his personal retirement.
Stick to the facts. And how many of those ANDAs have been executed? How many are sitting idle that we paid for that are doing absolutely nothing because they are worthless that we paid millions in shares for?
Love how CEO has been paid back the $1M loan and yet all we have today is the same - generics.
Twist and shout. Lol
ADT is the future of Elite's tech. Unless you like Elite bringing in a measly few million in revenues each year. I'd rather focus in the Billions.
But why not purchase them outright through Elite? Mikah getting involved isn't clear to me how that is in the best interest of Elite.
Interesting thought on Fentanyl, but in the end doesn't work with nalextrone & Elite's tech to my understanding. Bupe offers benefits, but creates addiction to itself in place of the opiate.
Yes, I agree here that this takes months and has been worked behing the scenes for quite some time. Thanks for your thoughts. Will be interesting for sure. Why do you think Nasrat would have done this via Mikah and not Elite?
We'll know more in time, but the whole situation honestly potentially seems a bit slimy. I think Nasrat, as he should, has kept in touch with Activis contacts. We pay for expertise & network. Elite bought the generics from Mikah when he came on board. Mikah already had those generics. Now that Nasrat has been with Elite for several years and for him to pursue another potential deal for Mikah to sell to Elite reeks of a conflict of interest. I hope this is not the case, but something doesn't pass the smell test here. Where is his time being allocated as Elite's CEO? Working on lining his own pockets first.