An investigational new drug application was filed in September 2006 with the FDA for MEM 3454. The FDA has advised the company that it needs more explanation for toxicology reports that were amended since the new drug application was submitted.
The FDA has also deferred assessment of the adequacy of the investigator's brochure for the trial pending submission of the additional information.
Memory Pharmaceuticals commented that a previous issue of potential impurities concerning the compound in its first drug application to the FDA had been resolved.
The company believes that no additional studies or data will be required to address the FDA's questions and that as a result, it should be able to provide the information necessary by early November.
“We are committed to resolving this issue as quickly as possible and, ideally, in a timeframe that would enable us to still initiate the phase IIa clinical trial for this drug candidate near the end of the year,” stated Jim Sulat, CEO of Memory Pharmaceuticals.