| 2003D-0570 - Guidance for Industry: GUIDANCE FOR THE CLINICAL EVALUATION OF WEIGHT- CONTROL DRUGS; Availability|
|FDA Comment Number :||EC2|
|Submitter :||Dr. Julie Krop||Date & Time:||03/30/2004 05:03:07|
|Organization :||Peptimmune, Inc.|
|Category :||Drug Industry|
| 1. Expectation of a 6 week run in period with plateau of weight prior to randomization is very unrealistic as a requirement for phase 2/3 weight loss studies-
2. Given current obesity epidemic and need for new therapys, agents with limited toxicity concerns should be able to file for approval with 1 year data and allowed to submit 2 year data during approval process.