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….
H, I would like that. When I made the note about the encouragement part, I was mostly thinking of me and the opportunities I have missed to share the Gospel.
Free will, what a concept! True that " It's up to them to believe or not", but it is up to us to sow the seed. Thank you for that. Also, the Bible states that this seed is "imperishable", and that should give us encouragement to sow that seed whenever possible.
I wish I knew for sure. I am hoping for a favorable outcome with the FDA, longer term, not necessarily with upcoming PDUFA. My AMRN holding has become a long term one for me. GLTY.
"This would be equivalent to preventing any of the myriad of studies regarding statin benefit from being presented and then saying Statins are the same as Zetia and therefore should not be approved.
• After meeting all of the agreed upon ANCHOR endpoints the FDA amazingly changed the requirements at the ADCOM meeting and asked the panel to predict the results of a future study.
• The FDA then indicated to the general public that trans-fatty acids – most of which are converted to Triglycerides in the body should be reduced. In direct contradiction to their statement that triglyceride levels in the 200- 500 mg / dl range should not be treated (If one wished to argue about inflammatory markers as a result of triglyceride consumption then this makes Vascepa’s position even stronger )
• The FDA then approved a drug (Antara) and their label, which states that lowering Triglycerides has no effect on cardiovascular outcomes – the very reason they rejected Vascepa!
• The FDA’s website still indicates that triglyceride greater than 200 mg / dl be treated
• The FDA indicates to Amgen and Sanofi that their new PCSK9 drugs do NOT need to prove they prevent heart attacks and death before they’re approved…. But Vascepa does !
When one views the ADCOM meeting at approximately 22 minutes in starts the confusion – Dr. Coleman advises panel members to use parameters considering Vascepa’s effect on CAD – he then says answer the question without REDUCE –IT (study on CAD occurrence) . These are DIRECTLY contradictory ! It would be like saying take the test with your calculator but you cannot use it. The fact that no panel member raised a question on this should be of grave concern."
And a thoughtful comment to that article:
"FDAinspector Dec 16, 2013 - 2:37pm
· The FDA could not reject Vascepa based on safety or efficacy so most amazingly they rejected existing standards of care indicating that Triglycerides between 200- 500 mg/dl not be treated. This groundbreaking information was never given to practitioners who continued to prescribe billions of dollars of medication to treat Triglycerides in the 200 – 500 mg dl range. The only public notification of this groundbreaking news was in an SEC Form 8-K to AMARIN investors.
· Since that time new guidelines have been release regarding the treatment of lipids. However, it should be strongly noted that the guidelines make no mention of any revision of triglyceride treatment parameters. They have neither removed or changed guidelines with respect to triglyceride treatment. The FDA has removed triglyceride parameters with no evidence as to why.
· We are all aware that the new guidelines indicate that treatment with statins should occur based upon risk factors alone The implication (as we have known for some time ) is that statins do more than lower LDL. Consider if Zetia had presented first to the FDA for the treatment of LDL. Utilizing the same logic that was applied to Vascepa (that since other meds that lower triglycerides do not change CAD incidence therefore Vascepa must not ) – statins would never have been approved - millions of life years would have been lost. Of grave concern therefore is the inappropriate inclusion of Vascepa in the same category as other medications that lower triglycerides.
· The FDA prevented the most compelling evidence regarding lowering of cardiovascular outcomes with EPA (Jelis Study) from being presented to the ADCOM committee. So not only was an inappropriate link made between Vascepa and other medications (as described above) actual evidence regarding the specific drug itself was not allowed to be presented. (cont.)
Second extension granted.
"Status Update! On Tuesday, December 10, 2013, status on the VONCERA trademark changed to SECOND EXTENSION - GRANTED.
On Friday, April 20, 2012, a U.S. federal trademark registration was filed for VONCERA by INSMED INCORPORATED, Monmouth Junction, NJ 08852. The USPTO has given the VONCERA trademark serial number of 85604083. The current federal status of this trademark filing is SECOND EXTENSION - GRANTED. The correspondent listed for VONCERA is Peter J. Willsey of COOLEY LLP, 1299 Pennsylvania Avenue, NW, Suite 700, WASHINGTON DC 20004 . The VONCERA trademark is filed in the category of Pharmaceutical Products . The description provided to the USPTO for VONCERA is pharmaceutical preparations for the treatment of respiratory diseases and disorders."
A similar update noting Lonspira, as well.