Replies to post #205589 on Avid Bioservices Inc (CDMO)

[biopharm]

CP, whenever that 1st look in may be, do you think its possible that by that time it could be possible that it could be based on some new biomarker (and even in combination with clinical outcome assessments) that has never been used before in any clinical trial?

I ask this, after reading parts of pages 28/29 on the post below and I find it sort of amazing that there would only be "3" qualified biomarkers in existence that have been used in previous trials and of course, with I/O = Immuno Oncology there must be many biomarkers ready to surface all that are directly related to "prove" the immune system is elevating back to normal to fight disease/cancer..etc.

Many BP's must be fighting to have a certain biomarker approved by the FDA and I wonder how many of them will also prove that Bavituximab is indeed working and ultimately, I believe one or more of these biomarkers could be used at the 1st look-in and provide a statistically significant surrogate endpoint. I also mentioned "clinical outcome assessments" because they can also provide some key insights vs the Bavi+Docetaxel arm vs the arm with no Bavi and just Docetaxel. I know... I just can't give up on this 1st look in and hopefully Robert Garnick has learned a way to take advantage of any new knowledge they have gained regarding the MOA and certain biomarkers they seek and convince the FDA they must utilize "outside science" as one would expect them to do. Peregrines Sunrise Phase III could be the very first trial where the FDA moves in the direction of approving drugs much earlier based on some new knowledge, in backing by the DMC and the scientific community at large.

Again, below are the questions the FDA ask of themselves and to the public for response and I thought science (math) was universal, not outside vs inside... so hopefully the FDA gets it right with some strong feedback by the scientific community that the FDA must get with the 21st century and accept outside science into their clinical trials.

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page 25 - How should the FDA rely on outside science when developing policy

".. Are there ways to help the agency, through regulating science or additional tools, be able to determine safety and efficacy for drugs given to large patient populations for chronic conditions other than multi-year studies requiring hundreds of thousands of patients"

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page 26 - Regulatory Science: The FDA must be prepared to review medical products in the future

"Addressing the scientific deficit is an important step towards more meaningully supporting medical innovation in America"

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page 27 - Inter-Agency Collaboration

"NCTR" = National Center for Toxicology Research with budget of $62.5 Million for FY 2014

page 28 - "NCTR has 34 projects in the area of biomarkers and is currently conducting 55 projects more broadly supporting personalized medicine, including research on biomarkers, technologies and tool development"

page 29 - Biomarkers: "..the use of biomarkers in drug development has been heralded as a way to shorten development times, find toxicities earlier in the development process and enable smaller trials. There is an entire public-private partnership at Foundation for the NIH looking at potential biomarkers, as well as other projects such as the Advancing Medicine Project. However, even with the focus and investment in biomarkers, only three have been qualified through the FDA's qualification program. Further, the three qualified already have been used in clinical trials for decades"

Clinical Outcome Assessment: 1) Patient reported outcomes 2) Clinician reported outcomes 3) observer reported outcomes 4) performance outcome

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=110532753

A more direct link to the Senate report itself (thanks to North40000 for providing it on here..)

http://www.help.senate.gov/imo/media/Innovation_for_Healthier_Americans.pdf

[MazelMan]

So if the first events of look in doesn't occur for a long period of time then we can assume that patients are surviving ? I don't recall the company stating that the first lookin is event driven.

D

[EYEBUYSTOX]

It's your opinion, but you're wrong. The e-mail was drafted last month and the documents (bavi launch scenario #1 and #2) were given to opposing counsel in 2014, months after the Fast Track designation was granted. All the fast track does is take off 4 months of review time assuming a priority review is granted vs. a standard review. There would not be a year difference in "Fast Track" approval vs. standard approval. That's also a fact.

I'm hoping the increase in Avid is to support the other trials with a partner that should have been started by now (TNB and Liver...maybe melanoma?) so we don't just have one, giant shot on goal but several.