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Biotech / Medical : Depotech(depo)

DEPO 7.300

+1.7%

Aug 14 5:00 PM EST

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To: John McCarthy who wrote (626)	12/21/1997 3:10:00 PM
From: John McCarthy	Read Replies (3) of 887

L I G H T H O U S E........................................... The purpose of this note is to: (1) Reconcile the past ODAC meeting (2) Present a FORMAT for understanding the current Phase 3 testing of DepoCyt vs Leukemia & Lymphoma & Solid Tumors I realize many already understand what has happened, so please move on, I'm just making sure I understand what has happened and what will happen. In addition, it may help just 1 more stockholder. Regards, John ----------------------------------------------------------------- Part 1 - Reconcile past ODAC meeting ----------------------------------------------------------------- ODAC VIEW OF DATA ------------------------------- ------- ------- ------ DepoCyt Cytar- Metho- abine trexate Total ------------------------------- ------- ------- ------ A A Total Population 31 30 61 B B Not Evaluable 0 0 0 ------- ------- ------ C A - B Adj. Population 31 30 61 ------- ------- ------ D D Responders 8 6 14 E E Responders Not Evaluable 0 0 0 ------- ------- ------ F D - E Adj. Responders 8 6 14 ------- ------- ------ G F/C % Responding 26 20 -- ======= ======= ====== DEPO MANAGEMENT VIEW OF DATA ------------------------------- ------- ------- ------ DepoCyt Cytar- Metho- abine trexate Total ------------------------------- ------- ------- ------ A A Total Population 31 30 61 B B Not Evaluable 7 1 8 ------- ------- ------ C A - B Adj. Population 24 29 53 ------- ------- ------ D D Responders 8 6 14 E E Responders Not Evaluable 0 1 1 ------- ------- ------ F D - E Adj. Responders 8 5 13 ------- ------- ------ G F/C % Responding 33 17 -- ======= ======= ====== Other Benchmarks cited DEPO News Releases: Based on: ------- ------- ------ Adjusted Population 24 29 53 ------- ------- ------ Benchmarks: Median Survival Rate - Days 168 87 ======= ======= ====== Disease Progresson - Days 108 48 ======= ======= ====== Toxic Side Effects 69% Better % ======= ======= ====== Notes: (1) DEPO Mgmt. REFUSES to explain the 7 people they termed Not Evaluable. (2) To steal a line from BIAO LUO - is DEPO Mgmt. CHERRY PICKING the Control Population. (3) (2) calls into question the VERACITY of DEPO Management. (4) The WORST side effects occurred with Methotrexate usage. 1 Death and 1 CNS. (5) Doctors who offered opinions on their review included Richard Simon , Steve Hirschfeld , Sandra Swain and Derek Ragavan. (6) The final vote was 7 against and 3 for. --------------------------------------------------------------------- Part 2 - Current Phase 3 for Leukemia & Lymphoma & Solid Tumors --------------------------------------------------------------------- What follows is a format for understanding the current Phase 3 test Depo is undertaking. I could not spread the data ACROSS the sheet so it is spread DOWN the sheet in 3 parts. PART A - Leukemia & Lymphoma PART B - Solid Tumors TOTAL C - Consolidated PART A: INDICATION:Leukemia and Lymphoma ------------------------------- ------- ------- ------ Unencap- DepoCyt sulated Cytar- Cytar- abine abine Total ------------------------------- ------- ------- ------ A A Total Population 40 40 80 B B Not Evaluable 0 0 0 ------- ------- ------ C A - B Adj. Population 40 40 80 ------- ------- ------ D D Responders 0 0 0 E E Responders Not Evaluable 0 0 0 ------- ------- ------ F D - E Adj. Responders 0 0 0 ------- ------- ------ G F/C % Responding 0 0 0 ======= ======= ====== PART B: INDICATION:Solid Tumors ------------------------------- ------- ------- ------ DepoCyt Cytar- Metho- abine trexate Total ------------------------------- ------- ------- ------ A A Total Population 20 20 40 B B Not Evaluable 0 0 0 ------- ------- ------ C A - B Adj. Population 20 20 40 ------- ------- ------ D D Responders 0 0 0 E E Responders Not Evaluable 0 0 0 ------- ------- ------ F D - E Adj. Responders 0 0 0 ------- ------- ------ G F/C % Responding 0 0 0 ======= ======= ====== PART C: INDICATION:Leukemia and Lymphoma & Solid Tumors ------------------------------- ------- ------- ------ DepoCyt Cytar- Standard abine Treatmnt Total ------------------------------- ------- ------- ------ A A Total Population 60 60 120 B B Not Evaluable 0 0 0 ------- ------- ------ C A - B Adj. Population 60 60 120 ------- ------- ------ D D Responders 0 0 0 E E Responders Not Evaluable 0 0 0 ------- ------- ------ F D - E Adj. Responders 0 0 0 ------- ------- ------ G F/C % Responding 0 0 0 ======= ======= ====== Notes: BIAO LUO has advised in Post 635 that 50+ patients (best guess) are enrolled in Part A. No numbers for Part B. The information above was provided by the following folks - Thanks! - John Andrew H. Biao Luo Baird Soule Miljenko Zuanic All errors and omissions are my fault.

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