Biotech Values

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ITMN:

Here are the draft questions sorry for the bad formatting the draft are available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203075.pdf and Adam posted his in his blog though I can't say if they are 100% accurate http://www.thestreet.com/_yahoo/story/10698217/1/intermunes-wins-positive-vote-on-fda-panel-live-blog-update-11.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA. They altered them slightly of note the last voting question was changed to be reducing decline in lung function (rather then IPF benefit to patients)

FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Pulmonary-Allergy Drugs Advisory Committee Meeting (PADAC)
March 9, 2010
HILTON WASHINGTON DC/SILVER SPRING
8727 COLESVILLE ROAD, SILVER SPRING,MARYLAND
Draft Questions to the Committee
1. Discuss the efficacy data for pirfenidone.
Include a discussion as to what constitutes a clinically meaningful effect size for the
change in percent predicted FVC.
2. Discuss the safety data for pirfenidone.
3. Does the data provide substantial evidence that pirfenidone provides a clinically
meaningful beneficial effect in the treatment of patients with IPF to reduce decline in lung
function? (Voting Question)
If not, what further efficacy data should be obtained?
4. Has the safety of pirfenidone been adequately assessed for the treatment of patients with
IPF? (Voting Question)
If not, what further safety data should be obtained?
5. Does the committee recommend approval of pirfenidone for the treatment of patients with
IPF? (Voting Question)
If not, what further data should be obtained?