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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by reifiedbeans on July 1, 2003, at 11:08:30
I know FDA approval is 4th quarter, but what does that mean for how long until it's actually available? Anybody know how these things work?
Interesting article about the drug here:
http://www.businesswire.com/webbox/bw.102902/223020378.htm
Posted by Jack Smith on July 1, 2003, at 12:48:49
In reply to How long until Cymbalta / duloxetine is available?, posted by reifiedbeans on July 1, 2003, at 11:08:30
> I know FDA approval is 4th quarter, but what does that mean for how long until it's actually available? Anybody know how these things work?
>
> Interesting article about the drug here:
> http://www.businesswire.com/webbox/bw.102902/223020378.htmInteresting article indeed. Sounds too good to be true to me but I am always pessimistic on preliminary studies before the drug is released. 79% response? A 69% remission rate is unheard of.
As for when it is going to be released, good luck in finding out. But I think once the FDA approves, it will be a matter of weeks. Lilly is itching to get this one on the market.
JACK
Posted by Geezer on July 1, 2003, at 22:05:20
In reply to Re: How long until Cymbalta / duloxetine is availa, posted by Jack Smith on July 1, 2003, at 12:48:49
> > I know FDA approval is 4th quarter, but what does that mean for how long until it's actually available? Anybody know how these things work?
> >
> > Interesting article about the drug here:
> > http://www.businesswire.com/webbox/bw.102902/223020378.htm
>
> Interesting article indeed. Sounds too good to be true to me but I am always pessimistic on preliminary studies before the drug is released. 79% response? A 69% remission rate is unheard of.
>
> As for when it is going to be released, good luck in finding out. But I think once the FDA approves, it will be a matter of weeks. Lilly is itching to get this one on the market.
>
> JACKHi Jack,
Numbers are not so surprizing when you take into account Lilly sponsored the article. Could be a good drug, very likely better than "Side-Effexor".
With Effexor you don't get any NA benefit until you get to about 200mg. Duloxatin should be a 50/50 effect for Ser. and NA from the first dose.They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
Geezer
Posted by reifiedbeans on July 1, 2003, at 22:54:28
In reply to Re: How long until Cymbalta / duloxetine is availa » Jack Smith, posted by Geezer on July 1, 2003, at 22:05:20
>> They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
>
> Geezer
>
>Why? Can you explain or give a URL? I thought there was some problem with the manufacturing plant. Surely saying that won't get a PBC???
You can email removethis-reifiedbeans@yahoo.com
Posted by Jack Smith on July 2, 2003, at 13:01:44
In reply to Re: How long until Cymbalta / duloxetine is availa, posted by reifiedbeans on July 1, 2003, at 22:54:28
> >> They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
> >
> > Geezer
> >
> >
>
> Why? Can you explain or give a URL? I thought there was some problem with the manufacturing plant. Surely saying that won't get a PBC???
>
> You can email removethis-reifiedbeans@yahoo.comYou are exactly right. It has not technically been approved by the FDA yet, not until the manufacturing problems are worked out.
JACK
Posted by Geezer on July 2, 2003, at 17:14:04
In reply to Delay » reifiedbeans, posted by Jack Smith on July 2, 2003, at 13:01:44
> > >> They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
> > >
> > > Geezer
> > >
> > >
> >
> > Why? Can you explain or give a URL? I thought there was some problem with the manufacturing plant. Surely saying that won't get a PBC???
> >
> > You can email removethis-reifiedbeans@yahoo.com
>
> You are exactly right. It has not technically been approved by the FDA yet, not until the manufacturing problems are worked out.
>
> JACKHi reified,
The first excuse given for the delay of this particular drug was a supposed problem with the Lilly computers (what ever that means). Now we are down to manufacturing difficulties (which may or may not be true). The point being the FDA is composed of a group of pencil-necked nazi bureaucrates who protect us from nothing and deny us everything.
It was the same when I worked in the medical device industry. All the long term testing with large groups of participants are conducted in Europe - the laws are more sensible there with fewer lawyers harvesting lawsuites (less risk for the companies) and this is where the real side effects and nasty problems are found. The problem is none of this information is admissable buy the FDA for consideration of the safety or effecacy of the drug prior to approval and release in this country. Often times the real delay is due to labeling and other such nonsense; did you need the warning on the cig pack to tell you smoking could cause pulmonary disease. There is a military term that applies here: "A bureaucratic cl..... F..." The delay helps the drug company to hyp the product and increase the demand and subsequent sales. If you think there is any altrustic motive behind it all you are sadly mistaken. There is some congressional push to speed up the process but you know politiciatians.
Geezer
Posted by Dr. Bob on July 2, 2003, at 18:44:45
In reply to Re: Delay » Jack Smith, posted by Geezer on July 2, 2003, at 17:14:04
> > > > > They had approval from the FDA over a year ago - if I explain the delay Dr. Bob will redirect or cancell this post.
Yes, general complaints about the FDA should be redirected to Psycho-Social-Babble, thanks.
Bob
This is the end of the thread.
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