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Nope. Quite upbeat actually.
Correlation does not imply causation
https://drive.google.com/file/d/0BwI9WYgqHk9mZTVwamJLU0NiM0E/edit?usp=sharing
https://drive.google.com/file/d/0BwI9WYgqHk9mbE1zSUpUY0kya0E/edit?usp=sharing
https://drive.google.com/file/d/0BwI9WYgqHk9mVTBfRU5OSEZFajQ/edit?usp=sharing
https://drive.google.com/file/d/0BwI9WYgqHk9mbTJTX01SQ0hiQmc/edit?usp=sharing
https://drive.google.com/file/d/0BwI9WYgqHk9mb0tSZGFxZ0pULXM/edit?usp=sharing
It was an excellent day. Had beers with AJ and Couch after.
Once I have my notes together I'll post some specific thoughts/observations.
But I really was very impressed.
Doug
Casual or suit to the meeting?
No.
Go back and look at Elite's earnings release history.
They report quarterlies in August, November, and February and they file their 10k in June.
First off, "we" is plural, not singular.
Dianne is their investor relations person. She is employed by the company. So yes, I find it very shocking that an employee would ever do what the CEO told them to do.
Give me a break!
10:30am
Continental breakfast before ... Nasrat buying lunch after
I'll be there about 9:30am
Mocha:
Nice start to the list.
Will you be at the SH meeting to pose these questions?
I will be there.
8/5/2013
You obviously never spoke with Dianne.
"Very Soon" conveys deep uncertainty?
Seriously?
The stock price was .075 on 8/5, the day the CEO was hired.
The stock price has increased five fold in less than a year.
What a CEO indeed!
Here's some information.
Isradipine launch coming soon. Very soon.
Right, sure.
"Marsh"?
So no one promised anything.
What exactly is the point of this discussion?
What was promised and by whom?
Never at the expense of security of proprietary information,
what shares have been "dumped"?
Maybe 2 million of 527 million shares traded per day?
.3% ??
Really?
Thanks glad you agree sgain
Market cap has increased 25 fold since 2010.
25
Vientecinco
My investment increased 50 fold and then some.
So for all the dilution, the bank analyst ceo, the QA analyst ceo, the also ran patents, I have made nice coin and.....wait for it....the company is way less risky with its generics pipeline and....wait a bit more...now is poised for explosive growth ...
The proof of the pudding is in the eating.
This company has proven to be quite tasty.
Finally you agree.
Sigh...
Must we explain everything?
Elites formulation was bio equivalent to a drug that....wait for it,,,,had proven efficacy in trials.
Bio equivalence nets us the efficacy DATA required to file.
Done and done.
Elite is not conducting efficacy studies.
They DONT HAVE TO!!!!!
They are relying on preexisting efficacy data.
So nothing to be filed.
LOL
LOL
LOL
LOL
LOL
Please figure out the difference between providing data and conducting studies.
Using this "also ran" logic my 2012 BMW would be an "also ran" car to my old 2002 BMW.
Fact is some patents improve on others. So they are not only unique (hence the patent) they are better than the "old" patent.
In the case of ELTP's patent their unique employment of a specific polymer made for a much better take on 2 bead system previously envisioned.
So if "also ran" means "unique and better"....I most certainly agree!
How is it incorrect?
Prove it.
Can you prove Elites technology is also ran?
What do you define as a "significant" market share?
Off to dinner music and cocktails
You kids have fun debating ad nauseum!
Are you implying that Elite won't have efficacy data? Cause they will.
Did not Elite and Camargo consult with the FDA prior to pursuing the 505b2 pathway?
So you think they are just "winging" it?
Seriously?
Is precedent required to succeed?
For the products Elite is currently working on via the 505b2 approval route, they do not believe that efficacy studies would be required. When I think of efficacy studies, I think Phase III clinical trials.
In the case of those products, we know the opioid will provide pain relief as long as the naltrexone is sufficiently sequestered.
Oxy once daily is a product that would most likely need a Phase III trial.
I hope that was stated clearly enough. I'm running out of posts.
Thats is how Elite is getting approval.
Is that too complicated for you?
They have started trials, didn't you read the PR's?
Agreed!
Good thing Elite will indeed be providing efficacy DATA in their 505b2 application.
Wow, glad that's all settled.
Next!
So again, what is your point?
Since you won't answer I'll try to help.
Q: Does the FDA require efficacy trials or efficacy data?
A: Efficacy Data
Q:Have not a great many drugs been approved via the 505b2 pathway without running an efficacy trial?
A: Yes
Here, read up:
http://www.camargopharma.com/Userfiles/Why-505b2-is-a-Whole-Different-Animal.pdf
Some key excerpts:
A 505(b)(2) application is one for which one or more of the studies relied upon for approval has not been conducted by or for the applicant. In these cases, an applicant may rely on published literature or on the FDA’s previous finding of safety and/or effectiveness for the drug.
In the end, the 505(b)(2) pathway can allow companies to move beyond the competitive environment of generics while still enjoying a development process that eliminates most preclinical studies as well as extensive safety and efficacy tests, dramatically reducing costs and time to market.
In contrast to drugs developed within the 505(b)(1) pathway, certain 505(b)(2) development programs require no Phase II or Phase III studies. For instance, in some (b)(2) NDAs, substantial safety and efficacy can be demonstrated through a single Phase I bridging study, if the systemic exposure is similar to the reference drug.
Yes, so what is your point?
First it's " Still no precedent for no FDA approval without efficacy data"
Which I easily dismissed with proof and links.
Now its "They have zero efficacy studies ongoing"
Which means what exactly? Why should anyone care?
True. But who said Elite wasn't providing efficacy data?
They will as part of the 505(b)(2) process.
See:
http://www.dddmag.com/articles/2012/08/taking-505b2-route
Drugs approved under 505(b)(2), on the other hand, can rely in part on data from existing reference drugs. This means they can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at much lower cost. Additionally, unlike generic drugs approved under Section 505(j), where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five, or seven years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the New Drug Application (NDA).
Regardless of the regulatory pathway one chooses for approval of an NDA, the FDA standards for the demonstration of efficacy and safety are the same; it is only the source of information that differs between the two paths. It is important to understand what constitutes sufficient evidence—and therefore which specific studies can be replaced by existing data for individual compounds.
Thats ok. we can all enjoy beers with Nasrat.
I'm local so if we all want to go out later I know the haunts.
Party in Senderos room!