- Jun 18, 2009
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Race Radio said:You really need to get your talking points clearer or you will just embarrass yourself.
1985 was when the human erythropoietin gene was isolated. It was not approved by the FDA until July 1989....but don't let the facts get in the way of your attempt to slime.
Well, since you want to talk timelines. EPO was isolated in 1977, 10 ml I believe, using a 7 step purification process. The announcement of the isolation of the gene was published in Nov. of 1985. But some of the literature imply that it may have been isolated as early as 1983. More importantly, the pivotal clinical study was published in Jan of 1987. Since that study was a phase 3 clinical trial, it could reasonably take between 6 and 18 months to complete and would use commercial product. That sets the date for production of the first commercial batch, a.k.a the bio-batch, to mid 85, at the earliest and mid 86 at the latest. Now, using the normal route for approval, it takes approximately 18 months from the time of submission to approval, and the first approval was received in June 27 of 1989, then the submission was made in Jan. of 1988. Remember that this BLA was pre-PDUFA, which means that the normal review process could easily have take three years, and there was no established fast-track process. In addition, this submission was at the agency during the restructuring that created CBER and CDER, which may have slowed down the approval process. So, this leaves all of 1987 to complete the additional phase 3 clinical trials in both the US and Europe using commercial product.
