if you had read my earlier post you would understand the scenario i am working under
1. the 12 month is significant for approval for IR
2. I believe IR goes on to approval , and MR goes to another trial ( either 3 or 6 months ) for reasons described before
3. everybody should know - the re-submission of an NDA yields a 2 or 6 month review - not a 10 month review
4. the efficacy and safety of indiplon IR will allow it to steal sonata's market share AND eat into the market share of lunesta and ambien - i have explained this many times before -
remember the initial drive study was done 9.5-12.5 hours after dosing ( that is what the FDA document says)
in the Q1 SEPR CC - they said they had new studies done 9.5-10.25 hours after dosing ( didn't say whether is was the lowest dose or not) - SEPR just will not do a 8 hours posting dosing test - because they fail it - in fact the indiplon drive study was done against lunesta and indiplon passed it while lunesta showed a ststistically significant impairment
bottom line is that lunesta has a 6 hour half life in a young healthy person - at 8 hours there is just too much drug left - there is even drug left over 24 hours the first dose when the second dose is given - and that is in healthy young people - as people age the time a drug stays in the system lengthens - so for lunesta it will be even worse
It will be interesting when Sepracor publishes its driving study on Lunesta and if you look at the published P3 Lunesta trial results you will see that Next Day Residual Effects profile is hands down better than Ambiem and I would say Equal to Indiplon, No advantage both appear well tolerated. FDA will not issue a Label to these class of drugs without a Next DAY Residual Warning" that includes Indiplon.
the mutagenesis covers two pages of the label
i might have 250 posts - but in those are probably 220 posts to correct your lies - you probably have 200 posts and none of them with a shred of data to support them - so you were dead wrong on ELN and probably got killed - and you are walking headlong into a haymaker again
Its about the "Label" no cancer safety issues in the label/package insert, so its a non-issue to the street and to PCP's who are the main Rx makers. you can push that issue to you have posted 10,000 mssg's on this board you already have posted over 250 in just 6 weeks,,,, fluff fluff fluff, who has time to read all your crapola.
you are a what?
I am a physician and a researcher - my friends from medical school run the gamut on specialties - i have told you what docs think of sales reps and how they don't believe a word they say - docs will listen to the reps spew just to get free samples - marketing clout just has to do with how annoying a drug company can be - I can guarantee you that if indiplon is just a flat out better drug like the data projects docs will switch to it because of hte efficacy and because they can finally get away from the risks of the knockout pills ( lunesta / ambien)
oh since when are you the expert on the sleep aid market??, its a sleep maintenance market it will always be a sleep maintenance market, so get over it. its all about marketing clount. as the overall labels between Indiplon, lunesta and AmbienCr have little differentiation to PCP's. Indiplon without the MR15Mg version is a sailboat without sails.
I do not argue that indiplon MRs dose has been coming down because it is plenty effective and they are tailoring it to work the best and not have the side effects of lunesta and ambien - BTW have you looked through the FDA AERs - for the one month i looked at i saw plenty of scary things ranging from accidents to completed suicides to psychosis - once i finish 3 months i will post that data also here and on the SEPR board - and I will send that to any analysts whose e-mail I have - and i will provide links and where the data can be found to back it up
keep on asking those off-base questions and i will keep digging and digging and posting and posting and e-mailing etc
you need to see the light - if i have the publically available data and you have none other than your skewed opinion I will just keep on burying you