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From: NTTG4/27/2012 7:34:38 AM
2 Recommendations   of 12993
 
Food for thought.... Not sure what it means for a company that hangs out in phase II for 3-4 years and still only has 80 patients and 1.0 MM PII studies, but an interesting perspective none the less. I guess when you don't have robust funding support you could take the cost efficiencies of PII approach, but.....


NATURE MEDICINE | NEWS


Analysis of drug failures underscores value of robust phase 2 testing Roxanne PalmerNature Medicine 18, 477 (2012) doi:10.1038/nm0412-477bPublished online 05 April 2012


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In the realm of drug development, many pharmaceutical companies—and their shareholders—are especially eager to reach phase 3 clinical trials, where candidate drugs are tested for their ultimate effectiveness. But an analysis presented last month at a meeting of the New Jersey chapter of the Licensing Executive Society emphasizes that companies are wiser to spend more resources working on fine-tuning their therapy in phase 2, lest they falter just in sight of the finish line.

“It's not sexy to hang out in phase 2 for three to four years, but that may be best way to develop a drug,” says Lisa Natanson, an analyst at Deloitte Recap, the San Francisco area–based, biopharma-focused intelligence arm of the international consulting firm Deloitte Touche Tohmatsu.

Last year, Natanson and her colleagues combed through information in the Deloitte Recap database from 190 mostly US-based biomedical companies on 97 compounds originated in house that reached a final clinical outcome in the US within the past decade. The analysis revealed that the 64 approved drugs enrolled a median of 171 participants in each phase 2 program and conducted two phase 2 trials, on average. By comparison, the late-stage failures—which were terminated at the phase 3 stage or rejected by the US Food and Drug Administration for problems with efficacy or safety reasons—enrolled a median of 69 people per phase 2 program and conducted an average of only 1.2 such trials, according to the Deloitte report. Moreover, smaller phase 2 trials did not reduce the time it took to help companies reach a final result.

Steven Paul, who retired in 2009 as president of the Lilly Research Laboratories in Indianapolis, says that the Deloitte data are consistent with his experience. He explains that business attitudes focused on near-term results are partly to blame. A primary reason for premature advancement to phase 3, he says, is “wishful thinking.”

But rolling out larger phase 2 studies is easier said than done for cash-strapped startups. To that effect, John Arrowsmith, an advisor at Thomson Reuters Life Sciences Consulting in New York, suggests that small companies that might lack funding for large phase 2 trials can conduct a preliminary version to get an early indication of efficacy as a way to attract investor interest. “It isn't a case of all or nothing in phase 2. You can get a sniff of success by running an investigative trial rather than a full-blown phase 2 study,” Arrowsmith says.

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To: NTTG who wrote (11206)4/27/2012 12:55:04 PM
From: TheMaster
1 Recommendation   of 12993
 
Lies, Damn Lies, and statistics! LMAO. 20 in phase I, 80 phase II, and I think the compassionate use number is 160. For a total of 260 MM patients + Breast, + Liver, close to 300. What the heck, makes a better argument if you use your numbers! lol BTW The TGA said they would incorporate the compassionate use #'s into their criterion which is 250 patients dosed.

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To: TheMaster who wrote (11207)4/27/2012 1:41:44 PM
From: NTTG
2 Recommendations   of 12993
 
I am pretty sure the article I posted this morning was in reference to PII trials and predictors of success. Thanks for confirming the 80 MM patient number...not sure what the rest of that was about?

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To: NTTG who wrote (11205)4/27/2012 5:52:27 PM
From: pro stock
2 Recommendations   of 12993
 
Thats why we question you

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To: NTTG who wrote (11208)4/27/2012 5:59:43 PM
From: TheMaster
2 Recommendations   of 12993
 
Do you think anyone believes your BS? 260 MM patients have received the drug. When you add in breast, liver + derm over 500 patients have received the drug. I only hope and pray that one day you are exposed for who you really are, I mean your true identity. I also hope that you get investigated for putting out deliberate lies to misinform the public to gain training advantage for yourself. And for all the gullible idiots who fall for your BS that call longs cheerleaders, I'll match my position against theirs any day. i put my money where my mouth is and no longer give opinion as to wether buy or sell the stock, certainly not in a chat room.

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To: TheMaster who wrote (11210)4/27/2012 8:50:31 PM
From: LT2011
3 Recommendations   of 12993
 
Why do you sound angry? Shouldn't each investor be allowed to listen to all views and decide for themselves?

Why do we need to be told how to think and who to listen to?

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To: TheMaster who wrote (11210)4/28/2012 8:44:29 AM
From: NTTG
2 Recommendations   of 12993
 
And from all those 'treated' patients, you can not point to one piece of objective evidence that PV-10 is better, worse, or no different from currently available therapies. Not one.

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To: pro stock who wrote (11209)4/28/2012 8:46:34 AM
From: NTTG
4 Recommendations   of 12993
 
Not a problem for me. My points of view and resources used in my evaluations are a matter of record here.

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From: Howard Williams4/30/2012 12:38:49 PM
1 Recommendation   of 12993
 
Health Issues April 30, 2012
ncpa.org

Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials

Though the United States urgently needs new treatments for common illnesses such as heart disease, stroke and diabetes, the nation's system for drug approval discourages innovation and investment, especially for our most pressing public health challenges. In this paper, Avik S. A. Roy, a senior fellow at the Manhattan Institute, finds that the main culprit is the high cost of Phase III clinical trials, which are required for U.S. Food and Drug Administration (FDA) approval of most drugs. Roy examined drug development in four major public health areas and discovered that for any given drug on the market, typically 90 percent or more of that drug's development costs are incurred in Phase III trials.

  • The enormous cost and risk of Phase III trials create incentives for researchers and investors to avoid work on medications for the chronic conditions and illnesses that pose the greatest threat to Americans, in terms of health spending and in terms of the number of people affected.
  • This avoidance, in turn, harms overall U.S. health outcomes and drives up the cost of health care.
The current Phase III trial system forces pharmaceutical and biotechnology companies to take enormous financial risks and burdens them with needless and unpredictable regulatory delays. The current system has, in particular, prevented start-up biotech companies, mostly based in the United States, from challenging the dominance of large, multinational pharmaceutical concerns. It also, perversely, encourages more innovation in drugs for very rare diseases than it does in drugs for common conditions that afflict hundreds of millions of Americans.

Roy recommends replacing the current "all or nothing" FDA approval system with one that reflects the realities of scientific research and the profiles of chronic long-term conditions. Such a reform would allow drugs that have been found safe and promising (in Phase I and Phase II clinical trials) to win approval for limited marketing to patients. This would give patients early access to innovative new therapies, while the FDA would retain the ability to collect information confirming the drugs' safety and effectiveness and to revoke a drug's marketing authorization later, when appropriate.

Source: Avik S. A. Roy, "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials," Manhattan Institute, April 2012.

For text:

http://www.manhattan-institute.org/html/fda_05.htm

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To: Howard Williams who wrote (11214)4/30/2012 1:16:46 PM
From: NTTG
2 Recommendations   of 12993
 
Interesting, thanks for posting. Of course the FDA did accelerate the final approval steps several years ago, is is exploring 'rolling PIII designs" to reduce the overall cost and time required to complete successful trials.....but it is very unlikely that they will give up the PIII requirement in the patent protected lifetime of PV-10. For most drugs that have gone through accelerated review processes have been approved with the proviso that the sponsor set up registries and REMS programs to monitor and address potential side effects that were not encountered in PIII trials, but happen in the real world.

fda.gov

fda.gov

fda.gov

fda.gov



Bottom line; is that there is no easy way to accelerate the process and assure patient safety. The FDA is actually moving away from approving drugs with 'similar efficacy' to other therapies, because the unknown risk with no benefit is a real safety concern. The proposed mechanism in this paper would be great for agents with a demonstrated superiority response (head to head) in PII trials, but that really would not apply here.

Would be interesting to see how much 'overhead' is spent on investigators and study centers in todays research environment. Cutting the Inst profit could go a long way to reducing the cost driver for PIII trials....just a thought

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