Avid Bioservices Inc (CDMO)

[Dragon Lady]

"Biomarker" HYPE versus reality....

The term "Biomarker" has and continues to receive much hype in the medical press, but despite a butt load of funding, numerous PR about "breakthroughs" and near earth shattering supposed "biomarker discoveries" etc...LITTLE has actually translated yet into any meaningful new cancer treatments and/or FDA approved products.

http://www.medscape.com/viewarticle/727018

Quote:

No Major Cancer Biomarkers in Decades, Despite Funding and Hype:

"Not a single new "major cancer biomarker" has been approved for clinical use in the past 2 decades, despite large amounts of funding and plenty of public-relations hype, according to an essay published online August 12 in the Journal of the National Cancer Institute."

"In the United States, one federal government program alone, the Early Detection Research Network, which is devoted to finding diagnostic cancer biomarkers, has spent "hundreds of millions" of dollars in a 10-year period but has yet to yield a single FDA-approved marker, writes Dr. Diamandis.

The overall futility is obscured by the fact that there have been multiple "breakthrough" cancer biomarkers that are highly publicized. However, long after the press releases are issued and news conferences are over, the markers are still not validated and quietly turn into failures, says Dr. Diamandis."

http://healthland.time.com/2010/08/18/cancer-biomarkers-dont-live-up-to-their-hyp/

Time Mag:

"Why cancer biomarkers haven’t lived up their hype:

"TIME: When these things do get published, they can get people’s hopes up, and get a lot of money for clinical implementation. What do you think is the best way to avoid this kind of false result?

ED: Unfortunately, diagnostics are different from therapeutics. When a therapeutic comes out, to get to the patient, as you know, there are very stringent criteria. Therapeutics have to get FDA approval. They have to do Phase I, Phase II, and Phase III trials, so there’s a very well defined roadmap. The diagnostics business is very different because we don’t have these stringent phases that people have to go through to make their case. If somebody says I measured this, in this patient, and this thing goes up or down, you can publish without too much difficulty. It’s only when something is published that other people say, okay, let’s see if it’s going to work. If it doesn’t work then we find out three years later. But eventually we will find out. I’ll tell you this much: If somebody publishes something substantial, of clinical value, somebody eventually will have to try the method, and if the method doesn’t work people will find out."

http://www.genengnews.com/gen-articles/cutting-through-the-biomarker-hype/978/

http://www.fiercebiotech.com/medical-devices/biomarker-research-suffers-from-too-much-hype

""With almost every paper, even if there is a remote chance of success, you see a press release hyping a discovery, but later on they fail," Srivastava tells OncLive. "The public gets so excited about it that they demand we must succeed as soon as possible. But the fact of the matter is, the hype usually does not translate into clinical studies." But Srivastava adds he is optimistic that, as the various branches of scientific research necessary for biomarker discovery come together, "more breakthroughs are a matter of time."

Knapp reports on some of the recent high-profile biomarker research failures--including flawed statistical analysis at Duke University resulting in tests that "turned out to be worthless, though they were once hailed as a breakthrough that was seen as the first fruit of the new genomics." The National Cancer Institute did a random review of 1,000 biomarker-discovery papers and found, Srivastava tells Knapp, that there was a lot of hype in 90% of the papers."

And so it goes.....PPHM is going to discuss in a "paper" about some "biomarker" that they "hope" ..."might"...somehow..."help guide"...."potential"...."future trials using BAVI-MAGIC"...."to potentially lead to a partner getting interested" and a blah..blah..blah....that's about ALL THEY'VE SAID SO FAR in the pre-hype PR about the big Monday "talk" at the ole "conference". NOT much else that I can see or that I read in their PR about the ole ESMO "conference" ???

NOWHERE, has PPHM stated (NOT that I'm aware of???) that they think this "biomarker a blah blah being found" is leading to some FDA insta-approval or some ability to leap-frog the Phase III FDA clinical trial process or anything of the sort...NOT that I've heard them state in public disclosed documents????

OH, and the REVERSE SPLIT PROXY, BOD RECOMMENDS VOTE YES ON ITEM 3, is STILL ON THE "agenda" for their shareholder meeting on Oct 13, FOUR, 4 SHORT days from now....why? Why have that needing approval if they're sitting on the "news" of the supposed cure for apparently every cancer ever known to mankind??? MAKES NO SENSE TO ME???? NONE???