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Biotech / Medical : Biotech Valuation

CRSP 56.76

+0.7%

2:14 PM EST

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To: Biomaven who wrote (19396)	3/21/2006 10:35:22 PM
From: zeta1961	Read Replies (1) of 52153

The media is neglecting to clarify what 1956 is proposing..Burroughs agrees with your sentiment.. page 9 ‘‘(5) Notwithstanding any other provision of 9 law, the Secretary shall prohibit placebo-only or no- 10 treatment-only concurrent controls in any clinical in- 11 vestigation conducted under this chapter or, in the 12 use of the last-observation-carried-forward conven- 13 tion, in any clinical investigation conducted under 14 this chapter or section 351 of the Public Health 15 Service Act with respect to any life-threatening con- 16 dition or disease where reasonably effective approved 17 alternative therapies exist for the specific indica- 18 tion.’’. 19 abigail-alliance.org I view this legislation as a positive step but by no means the definitive way in which to increase the speed that promising molecules make it to the patient..what makes it important, imo, is that he's cognizant that the current clinical trial system esp. for oncology is[has] outliving its utility..with all the targeted agents coming into the clinic, the advent of using biomarkers and the accumulated knowledge since the '70s..the system must change..Burroughs is also asking the FDA to use other data sources and statistical methods[ie. tumor registries, historical data banks and bayesian]to advance drug development[not new] ..the fear of snake oils is justified at first glance but all the tier 1 approvals will come with the same rigor and oversight that is currently applied the FDA..in truth, a very small select % of people already have expanded access and 1956 opens the playing field somewhat..note that only those with insurance coverage or the ability to raise money will have the priveleges of 1956.. Could it help the small bio's who have to compete with the the DNA's/PFE's brand muscle to recruit patients?..dunno but I do know that the current system in oncology is not sustainable.. Wonder what insurance payors have to say?..notably, ASCO has not publicly weighed in[that I know of] Elisabeth

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