Sounds like genr is trying to find the absolute minimum effective dose. Possibly all the more important because of the systemic delivery as well as something no doubt the fda would want to see.
1. Levitt claims the AMD timeline has not changed from prior guidance, i.e. that phase-3 will still begin in 1H05. However, I am somewhat skeptical that GENR can hold to this 1H05 timeline for the phase-3 start because results from the phase-2 combo trial with Visudyne may be needed for design of the phase-3 protocols and this trial just started enrolling patients today. (See previous message.)
2. GENR has not yet decided whether to release interim data on the AMD monotherapy trial which started enrolling patients in June. Enrollment in the mono trial is expected to be completed around the end of 2004, so some interim data is possible in early 2005. (Because this trial is double-blinded, interim data can be released only at pre-specified checkpoints or at the behest of the DSMB.)
3. Levitt says that GENR is looking for “phase 3 money” to partner the AMD program. This makes me wonder if GENR might be overplaying its cards as I suggested in #msg-4134703.
4. On the cancer front: GENR may have an update on the NSCLC survival data later this year, and GENR is seeking to expand the ongoing prostate trial from one clinical site (U. of Chicago) to two sites. I think these matters are of little consequence to investors, however.
The replay may not be available yet but it should be up later today or this evening. (Ignore the webcast link on GENR’s website, which goes to the wrong place!)
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