next generation pi

I have been disappointed at the rate the so called fast track has taken with the pi's. 4 or 5 years ago all the drug companys were talking 08 for fda approval. Now it looks like a couple more years at least. From what I understand the next generation pi's are far superior.  I wonder it they will have the same hoops to go through or will they sail along because of the trials of pi's before them?  Anyone have any idea?

                                                                                                                                                              Ron

                                                                                                                                                    

[dointime]

Here's my understanding on this.  The FDA are putting Vertex through the wringer because telaprevir is the first med which is going for a licence for a 6 month duration of treatment instead of a year.  The 6 month duration is radical because it flies in the face of previously held beliefs about the nature of HCV, ie. that it requires 48 weeks for all the infected cells to eventually die and be cleared out of the body.  

So I speculate that when Vertex is done jumping through all the FDA hoops and proves that 6 months works for those who RVR, then that will open the floodgates for all the other new drugs and the scientific understanding of HCV will have to be remodelled.

dointime