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re the petrofrezza,
i live in one of those nearby countries, and generally, I've never seen a group of people that looks more American in terms of body shape and general swolleness from the mcdonalds, kfc, hardees, and cheetos diet and lack of activity. (Don't get me wrong, I love all of those foods. but not 5 meals a day.)
This is not a dig at those that are struggling with weight, but those foods and the kind of sedentary life a lot of folks live here is unhealthy at best. It rains 5 days a year (maybe) and people lack vitamin D bc they don't get enough sun. seriously.
I digress, but I think a $200mm order would be a footnote on one of the gulf state's annual budgets. There are diabetes clinics everywhere here, and they are really struggling with the problem, it seems.
The convenience aspect would be huge in this market, and I think as soon as one gulf country starts using it, the others will quickly follow suit.
They will have to start making designer label inhalers though.
thanks for posting that, love to see the other side of the story too, but this made me laugh. looks like a show on a public access network: "Wealthmakers" 130am to 330am every Tuesday.
unless things have changed in the the past few years, it is not a req for the company to issue a pr for a conf call. only req i'm aware of is that companies have to report their results within 45 days of the end of the quarter (unless they file an extension request with the sec).
many tiny companies don't even have calls, they just put out a release with their numbers.
imo, if they're not ready with data by 8/15, they'll probably blast out a pr with Q2 earnings and then have a call to discuss it a few days later with data findings.
Oncostat,
thanks for the stats lesson! that definitely makes sense,it seems to be consensus that it's a low bar for 171, but I was just wondering how low and where that .4% fit in.
hi all, long time reader here.
great board, i've learned a ridiculous amount from all of you.
quick question for those with knowledge/experience of non-inferiority/superiority.
the tranche ii covenant regarding 171 is to show non-inferiority with a delta of .4% from the insulin aspart. I tried deciphering the fda's manual on non-inferiority, m1's, confidence intervals, p-values, way above me.
does this basically mean that afrezza with the next gen inhaler can perform .4% worse than the insulin aspart and still receive non-inferiority from the fda? Is that a standard tolerance for new drugs? Pardon my ignorance in advance.
I didn't see a % for the type ii study for superiority, is there a standard % that it has to beat the placebo by to prove superiority? i've seen .5% reduction in a1c's thrown around as a figure, but not sure if that is going off of previous studies or an actual standard necessary to prove superiority for the fda for new drugs.
Probably looking too hard, at the end of the day i want to hear non-inferiority for i and superiority for ii.
take care all and happy early 4th.