Originally Posted by
Dr. Potter
The application was pulled by the owners the owners for economic reasons. The FDA was asking for a $4,000,000 study to validate the bleach cleaning of the machine between uses BEFORE they would consider the application for a full committee. This type of thing is usually done afterwards as a contingency once approval has been granted. They felt that with PGD pregnancy rates being as high as they are that the market did I not justify this expense (or they did not have the money on hand to do it). There were not safety concerns with the off spring in the final data.That being said, I cannot be sure that what is being done in Mexico and elsewhere is the same process, is safe or works as well. They have not presented any data as of today. I will be curious to see if they do. If it is working well they probably would present at least preliminary data as an abstract. So far nothing.