SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : AMLN (DIABETES DRUGS)
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Cacaito who wrote (1300)4/6/1998 1:52:00 PM
From: David Bogdanoff  Read Replies (2) of 2173
 
C:

>>One alternative is to design very expensive studies to correct for insulin variance with statistical tools (Multiple analysis of variance), this is what the company is trying to do in my view.<<

Do you mean they are desiging new clinical trials? I don't think so; at least I certainly hope not. I think that they are more likely reanalyzing the data to adjust for insulin usage variability, as well as simply getting more data which will more readily show a small but medically significant effect at a statistically significant level.

If they show significant improvement in some subgroup of type II diabetics, then they can market the product for that subgroup and that will make the product available for all type II patients. This might also work if they just get it approved for type I diabetics.

The FDA would recognize the difficulties in conducting clinical trials and could grant them an approval with the requirement that they do long term post-marketing studies. So there are reasons to be optimistic.

David
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News