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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: biao luo who wrote (568)	12/18/1997 9:58:00 PM
From: Czechsinthemail	Read Replies (1) \| Respond to of 887

biao luo, Thanks for the information on the trials. If this is the case, I'm wondering what the options are for reconsideration of the data and/or the likelihood of a subsequent application with a larger number of patients included. I suppose this will be addressed in the conference call, but if anyone has any idea, I'd like to know. What seems bizarre to me is that Depotech would be presenting and interpreting the data in a way so far removed from the ODAC committee. I would have assumed there would have been discussions about it before today. Baird

To: biao luo who wrote (568)	12/18/1997 10:22:00 PM
From: Cymeed	Read Replies (1) \| Respond to of 887

"Not evaluable ?" Is this a term that is normally used in the medical industry and FDA ? The company must be using some kind of standard in evaluating their trial results ?

To: biao luo who wrote (568)	12/18/1997 11:03:00 PM
From: Miljenko Zuanic	Read Replies (2) \| Respond to of 887

To all: In my early posts I was concern about drop-off numbers and side effects of the DepoCyt. Today news show (at least according to press) that side-effects are main problem. Regards the efficiency, company did not give wrong data, but they did put positive spin on data! Thanks Biao, you explained well. How litle math can do a big swing. Anyway my understanding was that DepoCyt do not need to show better efficiency if side effects are reduced. Data on chemical arachnoiditis was unknown for majority investors. Suddenly this side effects (~65%) are main problem for FDA and it appears that they did surprise DEPO to. If drop-off is because patients died during study (and dead is not related to drug) than DepoCyt is significantly efficient. Otherwise there are no benefit because survival time for both drug become near equal. My condolence to all DEPO long. Including myself. For dogs and hyenas, who recently join thread with hype without knowing company and technology, my message is: this time you got it! mz

To: biao luo who wrote (568)	12/19/1997 12:32:00 AM
From: Andrew H	Respond to of 887

biao, your explanation makes sense and seems to explain the disparity. I had assumed that the 61 patients comprised the treatment group. I find it hard to believe they did a P3 with only 24 evaluable patients. That's just too risky. >>So the company and ODAC were looking at the same data, but somehow the company excluded the data from 8 patients who were regarded by ODAC to be 7 nonresponders to Depocyt and 1 responder to Methotrexate. The inclusion of these patients would significantly change the median survival time for each group. The company must have realized that the effects if exist are very marginal and more data was needed to convince FDA, so they started phase IV right away. But I doubt if the ODAC had a chance to see the data, at least not mentioned in the news. Also FDA is very suspicious about results from clinical trials with small number of patients. <<

To: biao luo who wrote (568)	12/20/1997 12:31:00 AM
From: John McCarthy	Read Replies (3) \| Respond to of 887

<<The problem is FDA and the company evaluate the trial results differently. Especially the seven patients (61-53=8) left out when the company evaluated the data. Company's opinion: Depocyt treatment: 33% (8) of 24 responded Methotrexate: 17% (5) of 29 responded ODAC's opinion: Depocyt treatment: 8 of 31 (24 plus 7 who were not evaluable in company's opinion and who did not respond) Methotrexate 6 (5 plus 1 who was not evaluable according to the company and happened to be a responder) of 30 (29 plus 1)>> biao luo - Hi. I'm late on this and I apologize. The post - part of which I reference above - that you sent gave complete clarity to a totally confusing and ambiguous situation. I cannot thank you enough. So thanks! Andy, if your reading this, DITTO. I know you don't own any but it was sure nice having your thoughts on the situation. Regards, John McCarthy