Posted by jrbecker on February 26, 2003, at 23:23:06
In reply to My apologies, posted by Jack Smith on February 26, 2003, at 15:35:04
No, I didn't ask on the timing of the approvability process. Since I was speaking to just a general operator at their help line, I assumed she wouldn't have any details on that issue. In talking to colleagues in the pharm biz and from reading up on the industry reports, it still seems anybody's guess when it might be approved. Lilly is preparing for an FDA tour of their facilities this spring, and I am told that this somehow has a bearing on their compounds that are in the approval process. It seems final approval is contingent upon labeling discussions and resolution of the company's outstanding manufacturing issues -- something possibly being investigated while the FDA is on site [yet I myself am not quite clear on this].
If I had to predict a date myself I would believe that it's in the next 3-6 months in terms of a release to the public.
The FDA has a made a big to-do lately of saying that they are trying to speed up the approval process for drug releases. Who knows whether this new PR-spin has any effect on duloxetine's fate.
But what I do know from participating in a couple of clinical trials is this: never judge a drug's efficacy based on its difficulty of passing FDA standards. Most of the hang-ups that delay, and sometimes even deny, drugs from approvability are much more related to the methodological issues of the study more than anything else. In taking advanced stats back in college and trying to design and carry out my own studies, I certainly got a taste for this first hand.
As for inquiring about whether I could participate in the trial - I didn't ask. Despite a good run with Effexor for two and a years, the SNRIs are probably not the best treatment for my specific symptoms. Although I'm always up for a trial of anything, so who knows.
If I come across, any updates, I'll let you know.
In the meantime, you might want to consider combining Strattera (a NARI, and also another Lilly med) with your favorite SSRI. This will give you a rough equivalent of what duloxetine might do for you (but on the other hand, who knows, every med is so different depite even slight tweaking of the molecules). But this way, you get to tailor the NE and 5HT ratio to your liking.>Sorry about that, you are right about the sarcasm, unnecessary. On a related note, did Lily have anything to say about when the stuff is going to be released to the general public? Also, did you express an interest in being in the trial? If so, how was that received?
poster:jrbecker
thread:204032
URL: http://www.dr-bob.org/babble/20030224/msgs/204199.html