Good to hear of the favorable costs to both you and festeringpus200.
g550, what are your blood work results (lipids, TG...)? I understand that the question may be deemed as a personal one and you do not have to answer.
All the best, GLTA AMRN investors.
"John Jenkins, M.D., Director, Office of New Drugs
Dr. Jenkins joined FDA as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1992. He subsequently served as Pulmonary Medical Group Leader and Acting Division Director before being appointed as Director of the newly created Division of Pulmonary Drug Products in 1995. Dr. Jenkins became the Director of the Office of Drug Evaluation II in 1999 and served in that position until he was appointed to his current position in January 2002.
Dr. Jenkins received his undergraduate degree in biology from East Tennessee State University in 1979 and his medical degree from the University of Tennessee at Memphis in 1983. He completed his postgraduate medical training in internal medicine, pulmonary disease, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia from 1983 until 1988.
Dr. Jenkins is Board Certified in internal medicine and pulmonary diseases by the American Board of Internal Medicine. Following completion of his medical training, Dr. Jenkins joined the faculty of MCV as an Assistant Professor of Pulmonary and Critical Care Medicine and as a Staff Physician at the McGuire VA Medical Center in Richmond."
Hopefully the egos are able to be set aside and the CDER/FDA does what it is tasked with:
To perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. We shall find out, GLTA.
Thanks. Is there a site where this info can be accessed? Otherwise, I will have to track based on homebuilders posted data. TIA.
Seasoned pharmaceutical professional with an extensive business development, strategy and financial experiences. Proven deal maker with an excellent reputation, extensive global BD network, exceptional financial and analytical skills, strong scientific background, good business acumen and a determination to drive deals & projects to successful conclusions.
Specialties:Sourcing product or company partnership opportunities. Managing multi-functional due diligence assessments. Conducting market research and estimating commercial potential. Robust financial modeling and analyses to value projects and terms. Developing appropriate positioning and communication strategy. Structuring and negotiating deals. Developing corporate, product or therapeutic area strategies. Assisting early stage companies in business plan preparation, BD projects and financing.
Vice President, Business DevelopmentAmarin Corporation
June 2013 – Present (7 months)Executive Director, Business DevelopmentACEA Biosciences
July 2012 – June 2013 (1 year)|Greater San Diego Area
Head of business development for ACEA Biosciences' Pharmacutical and Technologies business units.
President and FounderRD Consulting, LLC
2011 – 2012 (1 year)|Greater Philadelphia Area
Transaction advisory firm providing business development, strategic and financial consulting support for pharmaceutical, biotech and medical device companies.
Senior Director, Business DevelopmentAuxilium Pharmaceuticals
2004 – 2011 (7 years)Manager, Business DevelopmentTransform Pharmaceuticals
2003 – 2004 (1 year)Senior Associate, Corporate Business DevelopmentEli Lilly and Company
2001 – 2003 (2 years)Senior Research Associate, Pre-Clinical R&DHuman Genome Sciences
1996 – 2000 (4 years)|Washington D.C. Metro Area
BiologistNational Institutes of Health
1993 – 1995 (2 years)|Washington D.C. Metro Area
Incredible! Talk about acting with impunity. It is sad that this orginazation is responsible to protect the public concerning food and drug safety.
Thank you this information that you provide consistently. A question, should the NRx for Lovaza be "up", as the numbers are posted? Maybe they are transposed. TIA.
This is what is stated on the comment confirmation/receipt page:
"Your comment will be viewable on Regulations.gov after the agency has reviewed it, which may be an indefinite amount of time. Use your tracking number to find out the status of your comment."
Indefinite amount of time, our tax dollars hard at work!
On that basis, investors were betting that a big pharma that inks a deal with - or simply acquires – Amarin- would have a blockbuster on its hands, since the drugmaker hoped to steal market share from Lovaza, a $1 billion seller for GlaxoSmithKline (GSK). Zakrzewski, by the way, once marketed Lovaza for Reliant Pharmaceuticals, which was acquired by Glaxo.
But the panel vote and FDA rescission, which Amarin appealed (see this), hammered the stock – prior to the panel meeting, Vascepa shares traded at about $7, and are now hovering below $2. The FDA is expected to issue a final decision on whether to allow broader use, although such an approval seems unlikely. Just the same, a group of investors has petitioned the FDA to change its mind and approve wider use.
In the petition, they ask the agency to delay the December 20 approval date and conduct an independent scientific review of three outcome trials that were reviewed by FDA staffers, who maintained these raised “substantial scientific” issues and was used to justify the SPA, according to the petition. They also want the FDA to probe its staffers for possible misconduct.
Why? They cite an implied failure of timely communication to Amarin about their concerns; improper processing of FDA briefing documents; omitting key data and information related to the outcomes trials cited by the FDA medical reviewer; an “improper and imbalanced review” of the studies; improper handling of the FDA panel and improper rescinding of the SPA (here is the petition).
If this sounds like a last-ditch effort, well….