Biotech Values

[DewDiligence]

Erbitux:

Approved as both a combo treatment and as monotherapy, despite the fact that the BLA did not request approval for mono:

http://www.fda.gov/bbs/topics/NEWS/2004/NEW01024.html

Moreover, the allowance for treating patients who “cannot tolerate irinotecan” opens the door for doctors to use Erbitux after patients have failed first-line treatment with FOLFOX. My take on this is that the FDA has finally acknowledged that FOLFOX has superseded the Saltz regimen as the standard of care in first-line treatment.

I see no information yet on whether the FDA has imposed a restriction on IMCL’s manufacturing, as was widely rumored.

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Some folks appear to be very angry about the plunge in IMCL's price right before the trading halt. Another example of the danger of using stop-loss orders.

Could not resist the temptation to short a little more DNA when it popped on the Erbitux news. BMY’s stock has barely budged, but that’s not surprising given Erbitux’s small affect on BMY’s overall picture.