AI
Saturday, May 25, 2013 9:51:22 AM
2 quick reasons I really like Robert Garnick leading us thru the regulatory process… [ 2 of 17+ -;) ]...
2-26-04 - ATTACHMENT D – AVASTIN APPROVAL LETTER
From: FDA, To: Dr. Robert Garnick
FOLLOWED BY AVASTIN EXPANSION APPROVAL AS 2ND-LINE VS. MET. COLORECTAL CANCER:
6-20-06: From: FDA
Dear Dr. Garnick:
= = = = = = = = = = = = =
In 10-2009, Dr. Robert Garnick joined Peregrine as Head/Regulatory ( http://tinyurl.com/yga7z4x ). In his 24 years at Genentech (1984-2008; from Feb’01–Oct’08 as Senior V.P. of Regulatory, Quality & Compliance), he was responsible for 17 new product approvals, including most of DNA’s top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin, and Lucentis. He was responsible for all the regulated aspects of Genentech's business, including drug development, commercial production, and promotional & labeling compliance. As CEO Steve King said 6-29-11, “Rob is the ringmaster.”
• See this 6-29-11 Minyanville article, “Peregrine Pharma's Secret Weapon [Robert Garnick]” http://tinyurl.com/9jtnano
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
• All of Dr. Garnick's public comments (thru 5/2013) while at Peregrine: http://tinyurl.com/peq7xrt
• On 7-16-12, RG said this about the ongoing Bavi+Doce randomized 2nd-Line NSCLC Ph.2B n=121 trial (which is going to double+ MOS vs. Doce ctl-arm): "I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing an [EOP2] meeting with the FDA for Q4'12." http://tinyurl.com/cs7spbz
2-26-04 - ATTACHMENT D – AVASTIN APPROVAL LETTER
From: FDA, To: Dr. Robert Garnick
FOLLOWED BY AVASTIN EXPANSION APPROVAL AS 2ND-LINE VS. MET. COLORECTAL CANCER:
6-20-06: From: FDA
Dear Dr. Garnick:
= = = = = = = = = = = = =
In 10-2009, Dr. Robert Garnick joined Peregrine as Head/Regulatory ( http://tinyurl.com/yga7z4x ). In his 24 years at Genentech (1984-2008; from Feb’01–Oct’08 as Senior V.P. of Regulatory, Quality & Compliance), he was responsible for 17 new product approvals, including most of DNA’s top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin, and Lucentis. He was responsible for all the regulated aspects of Genentech's business, including drug development, commercial production, and promotional & labeling compliance. As CEO Steve King said 6-29-11, “Rob is the ringmaster.”
• See this 6-29-11 Minyanville article, “Peregrine Pharma's Secret Weapon [Robert Garnick]” http://tinyurl.com/9jtnano
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
• All of Dr. Garnick's public comments (thru 5/2013) while at Peregrine: http://tinyurl.com/peq7xrt
• On 7-16-12, RG said this about the ongoing Bavi+Doce randomized 2nd-Line NSCLC Ph.2B n=121 trial (which is going to double+ MOS vs. Doce ctl-arm): "I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing an [EOP2] meeting with the FDA for Q4'12." http://tinyurl.com/cs7spbz
