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Question....
Why did Nasrat get warrants? I wasn't aware that he was part of Epic Investments? Does this relate to his acting as a consultant to Epics CEO in the past?
Correct.
But I guess it begs the question, why and why now?
Should Ashok, Jeenarine, Ram and Nasrat start converting their warrants then cash would flow to Elite.
I guess look out for more form 4's on this.
OK, so they need efficacy data, which (since they are going the 505b2 route) they could get from the comparator drugs trial results?
They don't necessarily have to run a specific efficacy trial of their own unless the FDA feels that is necessary... correct?
So I guess we will see what comes out of Elite's meeting with the FDA.
Either way it's just a matter of time.
You mean efficacy data?
Interesting in Etrade just now:
Last Price Today’s Change Bid (Size) Ask (Size) Day’s Range Volume Trade
0.2967 +0.0137 (+4.84%) 0.220 x4,294,962,200 0.320 x2,500 0.276 - 0.300 27,799
So somebody put up 10,000 shares for sale at .28 and we will print .28!
Nasrat is a spry 53 years old,
http://www.navigant.com/~/media/WWW/Site/Insights/Life%20Sciences/DI_LifeSciences505b2_TL.ashx
The 505(b)(2) pathway is a particularly attractive choice
for those innovators because it offers both a potential for market exclusivity, and allows the innovator to utilize safety and/or efficacy data from the old drug to support portions of the new application.
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, added two provisions to U.S. law permitting drug product sponsors to rely upon FDA’s previous findings of safety and/or efficacy when registering new products. Under the law, both innovative and generic products can be introduced into the market without sponsors duplicating earlier, relevant clinical studies.
Section 505(b)(2) expressly permits FDA to rely on data not developed by the applicant to be considered for the registration of drug products.
Why do they need to start a study to provide data?
You do know how 505b2 works no?
As one of three types of new drug applications, the 505(b)(2) NDA allows drug companies to obtain Food and Drug Administration (FDA) approval of essentially “new” drugs without having to conduct the full complement of safety and efficacy trials, which is often the most time-consuming and expensive part of the drug development process. Because the 505(b)(2) NDA permits the drug manufacturer to rely on the agency’s findings for a previously-approved drug, published literature, or both, the typical 505(b)(2) application seeks to obtain approval for a modification of a previously-approved drug product, such as a change in dosing regimen, a new active ingredient or a new indication for use.
http://www.fdli.org/docs/default-document-library/fdli-monograph-vol1no6-preview.pdf?sfvrsn=0
Who said they wouldn't provide efficacy data?
I am impressed with the increase in share price and the potential for far more.
That is untrue.
It's hyped to the nth degree? By whom?
Oh never mind I know a straight answer is impossible.
They are conducting trials. Of course there are no approvals yet!
This is how it goes. Trials, submit to FDA and then get FDA approval and then go to market. Is that so complicated to understand? Why would anyone invest in an R&D pharma company without knowing that?
Only hype is available? The company has a $168,000,000 market cap. You don't get that with just hype.
What in the world does THAT mean?
Data bank?
Who suggested Elite has no competition?
Wow. Before everyone jumps off a bridge over this remember we have had Final rejections on past patent applications that ultimately were awarded patents. Nothing "Final" about a "Final Rejection".
Give this a read.
http://www.patent-innovations.com/documents/201009limitedmonopoly-finalrejectionisnotfinal.pdf
Oh really, which ones are you friends with?
Medications containing hydrocodone subject to new, stricter prescribing rules
http://www.providencejournal.com/breaking-news/content/20141005-medications-containing-hydrocodone-subject-to-new-stricter-prescribing-rules.ece
It was $.95 for about an hour and a half While it's been in the 30s for months and months and months which would you rather put weight on?
Sorry to prove how wrong that post was.....again.
Remember this post?
What is the stock price now?
Ballpark
11/17 is my guess
Zero is incorrect.
There are cameras outside the building FWIW.
Unless you knock on the door and ask for a tour not sure you will glean much but you never know! Maybe you will see the FDA there or a line of trucks loading API!
Maybe drop in at Biddy O'Malley's around the corner at lunch. Might bump into an employee or two.
I'm in North Jersey BTW.
Poison doesn't increase the share price five-fold. I don't think calling the CEO that has done such a fantastic job a RAT is called for at all. Not sure why this is a sticky.
Why is that funny?
Up since a month ago. I don't think anyone is getting their panties in a bunch over a one day .0005 decline. Especially when only .2% of the shares traded. To each his own I guess.
Posting it doesn't make it true.
Next.
You have proof it will?
Distinguishing opinion from fact isn't that hard is it?
No one EVER said that. If I am wrong please post a link to that post.
No results found for "there are 17 adts in development".
https://www.google.com/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=%22there+are+17+adts+in+development%22+
No you have not.
No, it's not.
No you did not. How long do you want to keep this up?
No you did not.
Context.
Where does he say ANYTHING about 17 products in active development?
Where??
Context folks.
Nasrat stated he could envision up to 17 possible products that utilize Elite's proprietary Abuse Deterrent technology.
At no point did Nasrat, myself or Couch ever state that there are currently 17 products in active development.
Elite has three ART products in trials.
Elite has four additional ART products in development.
Elite has plans for three additional ART products to begin development in 2015.
That's 10 ART products either in trials or in development by end of next year.
I'd say that's pretty darn good.
Is that true? What are the filing dates and application numbers?
And I am most certainly not "hyping". If anything I'm trying to keep things sane.
Don't worry, when J&J, Pfizer, Purdue or what have you buys Elite their army of attorneys will work on extending patent protection.