IMREG RESPONSE TO FDA ADVISORY COMMITTEE MEETING: FDA ANALYSIS

IMREG RESPONSE TO FDA ADVISORY COMMITTEE MEETING: FDA ANALYSIS "is seriously flawed and will be addressed by the company." In a Nov. 21 press release, the New Orleans-based R&D firm publicly took exception to "analyses and assumptions" on Imreg-1 presented by FDA reviewers to FDA's Vaccines and Related Biologicals Advisory Committee on Nov. 18. "Such misinterpretations could have been readily dealt with had FDA discussed their analyses with the company in advance of the meeting," the company said. At its Nov. 18 meeting, the FDA advisory committee deferred a final recommendation pending further review of the clinical data and discussions with the company ("The Pink Sheet" Nov. 21, p. 3). The Imreg press release maintains that the company had asked that the meeting be postponed to a later date to give it time to prepare its presentation. "For our part," Imreg said, "the company is eager to work in a constructive manner with the agency and the advisory committee to resolve these issues." "Telephone notification of the advisory committee meeting was given to the company on Wednesday, Nov. 9, at which time the company requested that the agenda and the specific data and analyses to be discussed at the meeting be sent to the company as soon as possible," the release states. "The company received a portion of this information on Tuesday, Nov. 15, and some additional material on Wednesday, Nov. 16, a full week after its request and only two days before the meeting, [and] company officials had less than 14 working hours in which to formulate appropriate responses." Imreg said it attended the meeting under protest after its request for postponement was denied by FDA. The company also noted that FDA staff, "in addition to the limited materials which had been provided to the company, presented a set of entirely new data and commentaries which had not been previously shared" with the company. Imreg's presentation to the advisory committee was prefaced by similar comments. "In particular, the assertion that the clinical investigators could decipher the code (which designated which patient received drug and which received placebo during the Phase III clinical trial) has no validity," Imreg President Arthur Gottlieb, MD, continued.