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Re: Nice Block. - AshI will not let that make me forget that Phase I was questionable and the first phase II failed at that time (although I believe under different testing later it was found to be good). - Ash Ash, it seems you have forgotten already. ;>) Phase I: Safety study. Fine or the trialing would not have advanced. Do recall that investigators thought they saw quite a lot going on with these patients, schizo patients with TD who were on drug. KG sorta said that their underlying schizo disorder may have been impacted from VMAT2 as well, not just their TD. Key words, may and have. Phase IIa: Post hoc studies are largely hated. I will give you that. However, due to the videotaping of all subjects and their evaluations, it was simple to prove, in living color, that one of the offices had a poorly trained evaluator. Phase IIb: Strong enough results to have a drug already fast track designated as breakthrough therapy. Too, there was NO QUESTION or trouble with the study. Do recall the stock reacted firmly to these results. Firmly, as in jumped out of its skin. I know some here had valid concerns about this drug(VMAT2), early on, and how it was trialed. KG made clear that the videoing of the trials is to NBIX's advantage, AND, the FDA is better than cool with it. Crabsully studied these trials very closely and communicated with O'brien. As he is a doctor, I defer to him and his thoughts on the subject. Further, Sully went from skeptical to flat out not. Perhaps he will expound on this subject for us. I know I breathed a sigh of relief when he grew bullish on the drug's merits and prospects. There are no sure things in life or the biotech industry. Anything can happen at any time, positive or negative. G'luck Bull |
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Msg # | Subject | Author | Recs | Date Posted |
38910 | Re: Nice Block. - Ash | ashtonb22 | 0 | 3/27/2015 12:40:53 AM |