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New filing requirements now.
Will be sooner
He will eventually but hasn't yet. What does that tell you?
.0625 to be exact
The chief scientific officer at epic just exercised a bunch of warrants.
Sophy Abraham, Ph.D, RAC
Head of Regulatory Affairs at Elite Laboratories Inc
Greater New York City AreaPharmaceuticals
Previous
DAVA Pharmaceuticals, Inc., Teva Pharmaceuticals, Ivax
Education
Maharaja Sayajirao University, Baroda
297
connectionsConnectSend Sophy InMailMore options
www.linkedin.com/pub/sophy-abraham-ph-d-rac/9/664/414
Background
Summary
Preparation, review, and submission of high quality regulatory submissions, ANDAs, amendments and post-approval supplements in accord with regulatory guidelines with minimal guidance.
Change control review and assessment of control documents to determine the appropriate regulatory mechanism and documentation for submission to regulatory agencies.
Review of DMF and Technical Packages received from vendors and manufacturing sites.
Interact effectively with cross-functional business units as required to prepare documentation for pre-approval and marketed products.
Train and mentor new associates on change control assessments, review of technical documents, and regulatory submission requirements.
Assign change control approvals routed through electronic document management systems to associates.
Assist management in the review of SOPs, technical documents and regulatory submissions.
Experience
Head of Regulatory Affairs
Elite Laboratories Inc
October 2014 – Present (4 months)Northvale, NJ
Regulatory Affairs Consultant
DAVA Pharmaceuticals, Inc.
June 2014 – October 2014 (5 months)DAVA Pharmaceuticals
Teva PharmaceuticalsSr. Regulatory Associate
Teva Pharmaceuticals
2006 – April 2014 (8 years)
(Open)1 recommendation
Diane Harper, PhD, JD, RAC
Diane Harper, PhD, JD, RAC
Associate Director - CMC Regulatory Affairs at Acorda Therapeutics, Inc.
Endorsement of Sophy's regulatory skills and expertise.View
Sr Research Associate
Ivax
1994 – 2006 (12 years)
(Open)1 recommendation
Sohagi Parmar
Sohagi Parmar
Method Validation Reviewer at Tris PHARMA
Sophy is very detailed oriented scientific professional and excellent working abilities in ARD and Regulatory areas.View
Post Doctoral Associate
Rockefeller University
1988 – 1991 (3 years)
Jason LePree
Vice President of Scientific Affairs at Elite Laboraties
Greater New York City AreaPharmaceuticals
Current
Elite Laboratories, Long Island University
Previous
Capsugel, Abon Pharmaceuticals LLC, Penwest Pharmaceuticals/Endo Pharmaceuticals Post Acquisition
Education
University of Wisconsin-Madison
446
connectionsSend a messageMore options
Relationship
Contact Info
Connected 2 months ago
Background
Experience
Vice President of Scientific Affairs
Elite Laboratories
September 2014 – Present (5 months)Northvale, NJ
Provide technical oversight for Analytical R&D, Formulation R&D and Quality Control.
Design, implement and oversee in-vitro challenge tests for abuse resistant narcotic formulations.
Design, implement and oversee pre-formulation studies to support development of immediate release and sustained release abuse resistant formulations.
Provide technical oversight for development of immediate release and sustained release abuse resistant formulations.
Program Director of Pharmaceutics and Adjunct Professor
Long Island University
1998 – Present (17 years)Hudson Graduate Campus, Orangeburg, NY
Instructor of graduate level courses: Pharmaceutical Analysis course and Physical Chemistry.
Program Director and Advisor (starting April, 2012)
I am responsible for student and faculty recruitment, student advisement, developing and authoring Outcomes Assessment Plans and Final Reports, and evaluation and redevelopment of Pharmaceutics Curriculum
Principal Scientist
Capsugel
July 2013 – September 2014 (1 year 3 months)Pearl River, NY (Site Closure Announcement October 2014)
Drug Delivery Technology Development
Use my prior experiences in Analytical Development, Preformulation and Non-solids formulations research to develop lipid-based dosage forms, including solid lipid particles, SMEDDS and SEDDS for administration in various formats including soft or hard capsules.
Formulations are developed for H&N (Nutraceutical) markets.
Abon Pharmaceuticals LLCResearch Fellow, Formulations Research and Development
Abon Pharmaceuticals LLC
April 2011 – August 2013 (2 years 5 months)Northvale NJ
• Develop formulation and processing steps for controlled release oral formulations
• Develop controlled release parenteral formulations
• Write documents for Regulatory submission including, Pharmaceutical Development, Quality Overall Summary and Quality Overall Summary, QBR for Sterility Assurance
• Use my pharmacy background to identify novel drug products for development.
Director, Preformulation and Non-solids Formulation
Penwest Pharmaceuticals/Endo Pharmaceuticals Post Acquisition
July 2007 – April 2011 (3 years 10 months)Patterson, NY
I am responsible for physical characterization of new chemical entities, including pKa determination, solid state stability, stability in solution, and solubility determinations and intrinsic dissolution testing using techniques such as HPLC and UV spectrophotometry and solid state characterization using modulated DSC, TGA and cross polarized hot stage light microscopy. In addition, I support all non-solids formulation development and manufacture for preclinical and clinical studies.
Key skills and accomplishments:
• Used lipolysis testing and other in-vitro tests to formulate and select lipid-based dosage formulations for preclinical studies, Phase I and Phase II studies for drug candidate, A0001. Became in-house expert in manufacture of liquid-filled hard gelatin and HPMC capsules.
• CMC team leader for drug development candidate and led a team of scientists including representatives from Analytical Sciences, Quality Assurance, Formulations, Non-solids, Quality Control, and a contract research organization to ensure drug substance and drug product were available for pre-clinical and clinical trials.
• Wrote the drug product and drug substance sections for the Phase I and Phase II INDs and Phase II IMPDs.
• Developed creams, ointments, and emulsions for development candidates for dermatological and rectal use. Verified physical and chemical stability of the topicals through stability studies.
(Open)1 recommendation
Saralena Martin
Saralena Martin
Librarian/Information Specialist
Jason is a very accomplished and innovative scientist who always finds ways to improve processes and get things done.View
NovartisResearch Fellow
Novartis
2006 – 2007 (1 year)
I supervised three scientists who assisted me in development and validation of methods for Assay and Impurity Analysis in support of two aggressive development programs.
Hoffmann-La RochePrincipal Scientist
Hoffmann-La Roche
January 2003 – August 2006 (3 years 8 months)
I developed and validated analytical methods for Assay and Impurity of drug products using HPLC and GC and dissolution methods tablets and capsules using both HPLC and UV spectrophotometry.
I was the first employee at Roche to earn Green Belt certification in Roche's Lean Six Sigma program.
Principal Scientist, Analytical Sciences
Boehringer Ingelheim Pharamceuticals
1998 – 2003 (5 years)
Dear ,
I have been on the phone with FINRA and OTC Markets about this issue most of today.
The problem appears to be with the stock quotes systems that receive their feeds from Thompson- which supplies the feeds for Yahoo, Google, among others.
I was on the phone with a brokers who both a Thompson terminal and a Bloomberg terminal – ELTP is quoted just fine on Bloomberg but not on the Thompson terminal.
I am able to get quotes just fine by logging into TD Ameritrade and Scottrade.
I am told by OTC Markets that this most likely will be sorted out by tomorrow.
Best regards,
Dianne.
My Etrade does not.
Dianne did provide that info.
My guess is Vicodin, Lortab, Percocet, or Percodan.
Dianne did not state if the 2nd co-drug was an analgesic and I doubt she would.
ELI-202 consists two active efficacious drugs and the sequestered naltrexone.
The active drugs have not been disclosed.
I just confirmed it with Dianne. Give her a call or shoot her an email yourself.
or Percodan (Oxy/Aspirin)
You said it was not Oxycontin.
How do you know it wasn't?
Can you prove it wasn't?
Of course not.
So you are saying the company is not telling the truth?
See:
http://www.elitepharma.com/product_pipeline.asp
Under branded drug it says:
"OxyContin"
"The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent to the branded drug"
picked up some .229's
Thanks!
.1% of the float is traded and the PPS is down over 13%.
A digital telephone replay will be available approximately one hour after the conclusion of the call for two weeks until December 3, 2014 by dialing:
Domestic callers: (800) 332-6854
International callers: (973) 528-0005
Conference entry code: 98840
Finally.
Next!
When did he "promise" an October meeting?
He referred to an October meeting back in August. Thought occur to you that they FDA had to reschedule?
Big deal.
Next.
Who the heck cares?
Point is now. They have met.
People sometimes only hear and remember what they want to.
This is Nasrat's quote from the previous CC. I tried to clean it up as best I could from the audio.
"Again, my vision is and has been for the past year and I've updated this with every single meeting. And it was the full order to my staff to deliver a filing by December of this year, and we are on target to do that. The only thing that could delay us, as I said before, no one can stop us. Elite’s anti-abuse is coming to the market. The only entity that could delay it is if the FDA requested one more clinical trial, which will put us out six months. We will know about that once we meet with them in October."
So, we ALL knew the FDA might delay this. Funny thing is they haven't said a damn thing yet. We have to wait a bit longer to know if they will or not.
Even if they do, no one can act surprised.
You remember wrong.
He stated that the FDA will be getting back to us with any further questions and or requirements. They (the FDA) needs to huddle amongst themselves and determine what else, if anything, they want from Elite before they file. It's a process. Nasrat was very clear that the FDA may require efficacy studies and pediatric studies. My read is that the FDA would like to give us the go ahead but as they haven't seen a formulation quite like this one they want to review internally to determine the most responsible path forward.
I for one don't take issue with the December promises. I knew full well that the FDA might delay this and Nasrat has stated that several times.
For that matter we don't know for sure yet if they will indeed delay. We need to wait for the FDA to reply and then Elite will PR that.
I think its great that he sets an aggressive goal for his folks to shoot for.
Would you prefer he just says "we will file when we file"?
No way, you would crucify him for being "wishy washy" or evasive or whatever.
Instead he stuck his neck out. I like that.
He stated "we are pursuing different sales and marketing models and that is one of the reasons I am on the west coast".
1,200,000 shares isn't exactly much...
Sounds all good to me.
You said:
"hmmmmm three months? sorry."
"ah, I see, so no information on the drug that went through in three months. got it LOL LOL"
I gave the information on two drugs. You are welcome.
It has happened apparently.
I'm not counting on it though in Elite's case.
But n2ka was certainly accurate.
http://www.nytimes.com/2012/09/01/business/fda-approves-prostate-cancer-drug.html
While the approval was not a surprise, its timing was. The F.D.A. approved the drug after only a three-month review, three months ahead of the deadline in late November. This is fairly rare, although a number of other cancer drugs have been approved at least a month ahead of deadline in recent years.
http://www.natap.org/2013/HCV/022213_01.htm
Kalydeco, the first available drug that targets the defective protein responsible for cystic fibrosis, was approved last year after a lightning-quick three-month review for the 4% of people with cystic fibrosis who harbor a particular mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene known as G551D...
This was pretty easy to find info. Not sure why it couldn't be found by others....oh wait....
0.330 x341,400
Bit of a wall...
http://seekingalpha.com/article/2433325-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-on-q1-2015-results-earnings-call-transcript
Unidentified Analyst
Good morning. I had one question and then I’d like to follow-up with another one if there is time. In your 10-Q they mentioned something about some arbitration of Phentermine with precession dose. And I was just curious if that was going to have any impact on the supply and if there is going to be any potential fallout to that in terms of costs in that arbitration.
Doug Plassche - Executive Vice President-Operations
Okay, I don’t think it will, like any partners you have contract that says when you have disagreements you go to arbitration. We have filed to the arbitration, however, we have not gone to an arbitrator yet, our lawyers are discussing it among themselves. It has not affected the supply from us to (indiscernible) precision dose or the pricing. And we hope to conclude and resolve issues over the coming few months.
Perhaps they don't need to.
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm078749.pdf
1. Extrapolation from Existing Studies
In certain cases, effectiveness of an approved drug product for a new indication, or effectiveness of a new product, may be adequately demonstrated without additional adequate and well-controlled clinical efficacy trials. Ordinarily, this will be because other types of data provide a way to apply the known effectiveness to a new population or a different dose, regimen or dosage form. The following are examples of situations in which effectiveness might be extrapolated from efficacy
data for another claim or product.
b. Bioequivalence
The effectiveness of alternative formulations and new dosage strengths may be assessed on the basis of evidence of bioequivalence.
c. Modified-release dosage forms
In some cases, modified release dosage forms may be approved on the
basis of pharmacokinetic data linking the new dosage form to a previously studied immediate-release dosage form. Because the pharmacokinetic patterns of modified-release and immediate-release dosage forms are not identical, it is generally important to have some understanding of the relationship of blood concentration to response, including an understanding of the time course of that relationship, to extrapolate the immediate-release data to the modified-release dosage form.
d. Different doses, regimens, or dosage forms
Dose-response relationships are generally continuous such that information about the effectiveness of one dose, dosage regimen, or dosage form is relevant to the effectiveness of other doses, regimens, or dosage forms.
Where blood levels and exposure are not very different, it may be possible to conclude that a new dose, regimen, or dosage form is effective on the basis of pharmacokinetic data alone. Even if blood levels are quite different, if there is a well-understood relationship between blood concentration and response, including an understanding of the time course of that relationship, it may be possible to conclude that a new dose, regimen, or dosage form is effective on the basis of pharmacokinetic data without an additional clinical efficacy trial. In this situation, pharmacokinetic data, together with the well-defined
pharmacokinetic/pharmacodynamic (PK/PD) relationship, are used to
translate the controlled trial results from one dose, regimen, or dosage
form to a new dose, regimen, or dosage form (See also section II.C.2.a).
Prove it
Why can't you trust the 10q?
and the PPS is up 7+ fold...not too shabby eh?
It's a typo. Nothing deceitful. Not sure why anyone would think otherwise.
Probably cause it didn't
Yes. Why is that funny?
You never made a typo?
We know a good company when we see one!