Biotech Values

[poorgradstudent]

The safety considerations for a replication competent virus and a purified protein do not have any relationship to each other, in my opinion.

I think that the "transgenic" label to GTCB's work provides it with more headaches than benefits. Really, they're simply a protein purification company. Some companies do it from bacteria or cancerous cells, GTCB does it in goats. Therefore, the safety concerns that the EMEA may have about GTCB's transgenic process must do with the absolute purity of the preparation such as trace viral contaminants, endogenous proteins from the goat's milk, etc... It can't *reasonably* have anything to do with the transgenic process of allowing the protein to be produced into the goat's milk.

Waiting for data from a US trial would be a reflection of the EMEA's skepticism about the clinical data to date, not a bona fide fear of transgenically derived protein.