Avid Bioservices Inc (CDMO)

[biopharm]

Yes Bio...this is very big. Dr.Garnicks attitude can be explained that with a look-in that can be determined by the information gathered by markers in the blood...that will mean that the Phase III approval can happen a lot earlier than some think.

Taking this a bit further and to show an example of what I believe the FDA has shown signs most recently of "accelerated approval" based on blood work follow:

First, I will lay out from the FDA's website the path that is most probable that Dr. Robert Garnick may be taking..... and then give an example from Roche received approval from what looks like to be from blood samples, rather than needing to wait longterm for overall survival.

About the Accelerated Approval Regulations

Under Subpart H, approval may be based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity ("Surrogate") [21 CFR 314.510], or a product may be approved with restrictions to assure safe use ("Restricted" ) [21 CFR 314.520].

FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ucm121606.htm

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Next, here is the example from Roche that I believe was based on blood work...

Roche’s new timesaving formulation of Herceptin approved in Europe for the treatment of HER2-positive breast cancer

Sept 2, 2013

The European Commission’s approval was based on data from the HannaH study which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR) to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels. Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting. No new safety signals were identified.

http://www.roche.com/media/media_releases/med-cor-2013-09-02.htm

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Now, only a month later..

FDA grants Roche’s Perjeta accelerated approval for use before surgery in people with HER2-positive early stage breast cancer

Oct 1, 2013

This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin (trastuzumab) and docetaxel chemotherapy had no evidence of tumour tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

http://www.roche.com/media/media_releases/med-cor-2013-10-01.htm

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Taking a look back... and taking it further to understand where this "Pathological Complete Response" term is coming from....

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

Tatiana M. Prowell, M.D., and Richard Pazdur, M.D.

(this is the 5th paragraph down... in the link provided) yes CB... we need links to show where ones opinions are derived from

In the United States, regular approval of a new drug requires adequate, well-controlled trials demonstrating clinical benefit, which is generally defined in early-stage breast cancer as an improvement in disease-free or overall survival. Alternatively, the Food and Drug Administration (FDA) may grant accelerated approval on the basis of a surrogate end point that is “reasonably likely to predict clinical benefit.” For neoadjuvant breast-cancer treatment, we propose that the rate of pathological complete response be used as this surrogate.2 After accelerated approval, demonstration of an improvement in disease-free or overall survival would be required; the indication may be withdrawn from product labeling if confirmatory trials have not shown clinical benefit.

http://www.nejm.org/doi/full/10.1056/NEJMp1205737

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So back in 2012, Dr. Richard Pazdur- The FDA's cancer Czar gives the opening of allowing "accelerated approvals" based on a surrogate endpoint "other than overall survival..etc" and now we see Roche doing exactly that most recently.

I believe Dr. Robert Garnick has the plan and Dr. Garnick left Genentech and eventually landed at Peregrine Pharmaceuticals for a reason-- those reasons I believe will be seen over the next couple months.

Dr. Hal Barron also used to work for Roche/Genentech, where Dr. Robert Garnick worked for 24 years and he had something to say about Roches latest approval based on "Pathological Complete Response"

Oct 1, 2013 -- same link as the Oct 1st link above...

“A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Together with the FDA, we’ve charted new territory. We look forward to working with health authorities around the world to explore additional ways to bring promising medicines to patients more quickly.”

This new neoadjuvant indication for Perjeta is for use prior to surgery in combination with Herceptin and docetaxel chemotherapy...

http://www.roche.com/media/media_releases/med-cor-2013-10-01.htm

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Sorry to make this post longer than I originally intended...but I see the writing on the wall: "new approval pathway" "Pathological Complete Response (Pcr)" "blood tests" "alternative surrogate endpoint" "several years earlier than previously possible" --

and just to note: Dr. Hal Barron now works for Calico now, hired by Calico CEO = Art Levinson who was former CEO for Genentech, who in turn was Dr. Robert Garnicks old boss = whom ALL probably didn't like Roche disturbing their ways of research and development.

Nov 19, 2013

http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/11/calico-levinson-google-hal-barron-age.html
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Dr. Robert Garnick arrived at Peregrine Pharmaceuticals seeing something in Bavituximab that I believe..... he believed showed much more potential on a much wider scale than Avastin/Rituxan/Herceptin..etc and now Dr. Hal Barron leaves Genentech for Calico- California Life Comapany = A Google backed Health Venture with Billions in the coffers they may be very ones to help increase those Big Pharma nightmares.

One just has to wonder if history repeats itself where all these very knowledgeable Genentech workers will all be back in the same circle, yet again.