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 : Depotech(depo)
DEPO 7.300+1.7%Aug 14 5:00 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Cymeed who wrote (574)12/18/1997 11:17:00 PM
From: JQAR80A  Read Replies (2) of 887
 
First off, I totally disagree that DepoCyt is dead..and bear in
mind that I was no big optomist on this product in the first place.
Near the end of the panel meeting, the panel generally agreed that it could revisit the data once Depotech submits additional clinical data
from clinical studies testing DepoCyt in lymphoma and leukemia
patients. I think I am going to reserve judgement until I see this data. Secondly, if you look at the statements of the panelists who
voted against this it is not all doom and gloom. Panel member Victor
Santanna said that he was unsure if he could form an accurate assessment of DepoCyt using the surrogate endpoints Depotech used
in clinical trials of the drug. Santanna would have have preferred
a "hard endpoint" that specifically showed the drug's benefits.
Kim Margolin, another Fda panel member, indicated that Depotechs's
study was not large enough to form an accurate opinion and she wished
the company had performed some type of confirmatory study. Another
panelist, Derrick Raghavan said that Depotech's trial was extremely
small and the "numbers aren't there, but I don't want to lose a
potentially beneficial drug." In the end. Raghaven was not able to
vote for approval due to lack of clinical evidence.
I guess what I am trying to say is I think the door is still open
once DepoTech submits more data. And in all fairness to the company
Depotech and the FDA agreed before the trial began to look at trends
within the trial because of the small sample size. I'd like to look
at the phase IV information before I make up my mind whether this
product is viable or not.
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