OMG - read this on ARRY

Great find by CL and wonderful story that should catapult Array into the spotlight. However, it needs to be published beyond the "LaFayette Camera"... a publication in Boulder,home of the two involved biopharma......This story should be on 60 Minutes and its ilk. Miami

Great story.

Reality is, there have been more than a few instances of CRs where the intervention did not pass muster with the statisticians.

It is, IMO, the misguided premise upon which more than a few drugs who benefited a few were rejected.

If a drug saves the lives of 10 kids out of 200, and placebo "saves" the lives of 10 out of 200, the detached bean counters call it "insignificant."

Thing is, any sentient person knows that a sugar pill does not save lives.

I would hope that ARRY makes breakthroughs. They have an uphill battle considering the mindset of the FDA.

Once again, it was not until the Thalidomide fiasco that the FDA was tasked to decide on efficacy of a drug or device. Prior to that, their role was to evaluate safety and safety alone.

Given the vast numbers of drugs and devices, once approved to be both safe and effective, and now subjects of class action lawsuits for injury to patients, how can anybody believe that the FDA is capable of determining either?

But that is the way it is. And given the nature of all bureaucracies, their first priority is self preservation. Second priority is expansion. Somewhere down the hierarchy of priorities is doing what they were mandated to do.

Pcyc had similar stories from their patients who were taking imbruvica around phas two. Later on imbruvica was approved for three indications. Later on abbvie bought it for 260 a shRe

I looked to see which drug it is, and ARRY has it partnered with Genentec.

Phase 1 and phase 2 studies:
www.clinicaltrials.gov/ct2/results?term=Ipatasertib+OR+GDC-0068&no_unk=Y

ARRY has a TON of partners ON several drugs. They ALSO own a few and are developing those and have submitted one to the fda, with a second submission coming soon. THING with many of their drugs that are partnered is there are many many phase studies going on, too many to track.

GREAT to see this ARRY INVENTED DRUG help this girl. SURE that GENENTECH and ARRY are looking at this in a major way.  What I missed MISSED on the first read was that it took a new genomic TEST to discover a MUTATED GENE previously unknown first then hunting down a drug that targeted the unmutated gene and it appears to have worked.

JB.



www.arraybiopharma.com/product-pipeline/other-compounds/ipatasertib-gdc-0068/