"Perhaps the reason why KK was saying that is because they knew the results of the Prime study were disappointing and were trying to lower people's expectations. "
No, because as soon as they announced they were cutting PRIME in half they said that it was no longer powered for statistical significance
I think one of the analysts asked that question but they did not get that specific other than to say there was no statistical difference. If someone emails Ian that question he may give out those details. They did say they were still studying the data so they may have been reluctant to give it out when they are not prepared to discuss the specific data. But that is only a guess on my part.
When you look at what KK said at the two conferences and what he said today, it was clear this negative MS data was not available to him and the management team (they said at the CC that it came in during the last few days) as of the date of the earlier two conferences..However, I don't think its going to change Avanir's plans for a DPN Stage III study using low Q dose AVP-786...because the prior DPN data met most secondary endpoints and was quite positive..
Sentiment: Strong Buy
Perhaps the reason why KK was saying that is because they knew the results of the Prime study were disappointing and were trying to lower people's expectations.
Unfortunately no one picked up the hint
Thanks but in all fairness to Avanir, they knew when they cut PRIME almost in half that they were no longer powered for statistical significance.
I think the time they were saving was more important to them because they rightly have confidence at least in the 45 dex/10 quin dose to proceed with a dose of deut-dex/quin that gives the same dex level in a sufficiently powered Phase 3 for diabetic neuropathic pain.
Do we know what the p value was versus placebo for the 45 dex/10 quin arm?
Anyone buying this trash is dumber then hell look at the market cap then look at the huge losses negative cash flows book value ect this stock is a bloated pos
Sentiment: Strong Sell
At least avnr after hours is 3.60 per share higher than where Rim's last stock call opened at. Between his and Berts ringing endorsement of MF Global, we're still looking GREAT ! :)
Sentiment: Strong Buy
Hey, you win some and you lose some. Looks like I'll be stuck here for awhile with a small long position again.
It is not about the MS study, it is about designing the right clinical study for DPN.Here are some more comment from Katkin.
So you take that and then arguably the most, the most definitive data that we have is a large well controlled phase 3 program in diabetic peripheral neuropathic pain, and this was done a number of years ago, using a different dose formulation of dextromethorphan and quinedine, but that study was under an SPA with the FDA, had just shy of 400 patients in three arms. We achieved the primary endpoint in that study with strong statistical significance. We also achieved statistical significance on five of the secondary end points. And so that's the most definitive data. So there's no doubt in our mind that 786 and 923 work in pain. The question is as designing the right clinical studies which demonstrate that treatment effect