There are some good posters on Kosan's Yahoo board. This is what Neblo had to suggest about recent developments.
Re: Cardiac effects
by: neblo 08/15/05 07:11 pm
Msg: 1059 of 1102
>>The Kosan press release says they were notified on Friday. That is a clear statement of fact that I I doubt Kosan would screwed up.
Notified formally means one thing. Knowing that this is likely to happen is another, and rarely are companies caught completely by surprise, as they talk to the trial sponsors all the time.
>>I find it interesting the only reference to EKG problems is with 17-aag, but the DMAG is required to have the same testing.
That is because at present it is not known whether the effect is caused by something about the formulation of 17-AAG, 17-AAG itself unrelated to inhibition of Hsp90, or due to inhibition of Hsp90 in particular (mechanism-based).
Further, it is true that of what was disclosed, it suggests that the effect was limited and did not sound terribly alarming. But we don't know if everything was disclosed (the norm in biotech is that there is always more than meets the eye), but we will watch with caution for any future black box on cardiotox, that may limit the use of the drug.
I do accept your point about the secondary not being obligatory if anything about the company changes. If KOSN released this info now precisely because of this, then they did well and will avoid any liability. Especially because this info, absent any secondary underway, probably would have been swept under the rug. |
