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: John McCarthy who wrote (633)12/20/1997 6:34:00 PM
From: biao luo  Read Replies (3) of 887
 
The 120 people were for both leukemia, lymphoma and solid tumor. They originally planned to enroll 60 for each group. The enrollment for leukemia and lymphoma is not complete. During the conference, CEO mentioned they have 50+ patients for leukemia and lymphoma according to my memory. But because of the ODAC's criticism of their solid tumor data, they will talk to FDA to see 60 is still a satisfactory number. The drug has to be significantly better than the control to achieve statistically significance in 60 patients.

I am confused about one thing. On one hand, they said Depocyt achieved 60% response in lymphoma, while ara-C alone had 10% response; on the other hand, they said interim analysis of clinical trial data is a no-no. So are these numbers from phase II? They commented the 10% was lower than other people had seen.

The difference between "intend to treat" and "evaluable" cost the company this failure and a surprising financial loss to shareholders. I don't think CEO gave us a satisfactory explanation. He was a little irritated and said they chose evaluable patients based on some predetermined critria. But why were there 7 not evaluable in the experimental group and there was only 1 in methotrexate group? Was that because of increased toxicity and side effects? He didn't give a detailed explanation and this would cause some suspicion that cherry picking of the patients was involved. That kind of irresponsible and argumentitive attitude is worrisome.
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