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Very informative conference call. Here's my version of the highlights...

1) Circle Feb 4-9 on your calendars for the 8th Conference on Retroviruses and Opportunistic Infections in Chicago.

Abstracts from all current clinical trials have been submitted, including the T20-204 trial in children, the T20-206 trial with a control arm, the T20-208 new formulation trial, continuing data from the T20-205 trial, and data from both arms (??) of the T1249-001 Phase I/II (???) trial. Preclinical work will also be presented, presumably dealing with resistance development.

Not sure I heard the both arms portion of T1249 correctly, nor seen T1249 designated as a Phase I/II, but this suggests that another arm has been added to the T1249 Phase I.

They stressed that these abstracts had been submitted but not accepted, although they hoped most would be presented in either poster or seminar form. Take home message is there is a ton of data coming out in Feb, and it is very likely going to be extremely positive.

2) Two arms of T20 phase III. T20-301 is the North/Central/South American trial at 48 sites. 3-5 sites have already been initiated. T20-302 is the European/Australian trial, and sites will begin to be initiated by the end of the year.

3) Timeline...

I. Patient accrual completed within 6 months of initiation, meaning mid 2001.
II. Trial results presented in Winter 2002 at retrovirus meeting.
III. NDA submission Spring 2002.
IVa. Approval and marketing Fall 2002.

Feel confident of full scale production at Roche Boulder (metric tons of T20) in this time frame.

4) Unfortunately, no questions asked about T1249. Has it been scaled up? Timeline for progression into Phase II? Directly into Phase III?
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