FDA position on Serada NDA approaches. If the FDA allows the filing...
What's going on here? How seriously is the FDA considering this? When will they decide? How likely is it that DEPO would get an o.k. on a Serada NDA given that their trial was unsuccessful with the statistical method that they specified before the trial? Thanks.
Since it's not a public document, I haven't read the SPA, like Chip claims to have done. But I do know a little more about it than most people and I stand by my predictions--no additional trials, NDA filing this year and better than 50/50 odds of approval.
The PR info detailing the design of Serada's trial 3 study provided by chipper does not tell us what DEPO can do to get Serada approved by the FDA. The failure of the Trial 3 study to meet the easier .05 p requirement that the results were due to Serada's efficacy (95% likely) is not easy to overturn. I agree with chipper that its not likely to happen, but there is always hope. Gralise is the main positive now.
There goes Fabian again reading my posts after he says I've been put on ignore.
"I'm laughing at the superior intellect."
"One of the problems the internet has introduced is that in this electronic village, all the village idiots have internet access."
Implies he has read it:
Refuses to cite location because he hasn't read it:
Admits to not having read it:
Busted. At least I pointed to the source of my information. But not this crackpot.
of course, 2to3, you can always just ask the CHIPPER. He's read it and has it handy!
Yeah, right! Its right by his bedside night table-got a few coffee stains on the front page and its a bit crinkly from all that toilet reading. Just post a few paragraphs on the yahoo chat board for us all to peruse.
Chip: Thanks, but I saw that PR when it first came out. What I was looking for was the actual SPA - the details therein will undoubtedly contain the key as to Serada's liklihood of making it through the NDA process. I suspect the actual SPA document is extremely confidential.
"How likely is it that DEPO would get an o.k. on a Serada NDA given that their trial was unsuccessful with the statistical method that they specified before the trial?"
A tally of the posts on this board on this subject are pretty split, with a slim majority saying "no go", you dance with the one who brung ya.
However, I don't think DEPO is looking to submit a NDA from its current position, but rather a path that will get DEPO to submission of a NDA. My guess is that DEPO will be asked to do another trial, combining the new results with those from its previous trials. Whether this new trial can run after submission of the NDA is questionable. I think the FDA will given them a path to victory, but it will be a 6-month long and costly path before submission.
I wonder which statistical techniques they'll use the next time around. They could still screw it up by choosing the wrong one.