Replies to post #9028 on 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.

[kaivamei]

Rstor1: ONCY

+++When I asked the CEO about the delay with the US trial, he said that the FDA wanted to wait for definitive safety results from the HC trial before giving the go-ahead (which came a couple of weeks ago.)+++

Interesting: so it was essentially the worst case regulatory scenario, albeit now drawn to a close. Of course, the silver lining is the assurance now provided that the HC safety data is positive.

I wonder if this means that the Canadian results could be in such shape that they might actually be released soon?

When you spoke to BT, did you get a meaningful response to the question about whether glio enrollment is complete?

What else did you learn from Dr. T?

(Email me privately if that would be more appropriate.)

Thanks,

-kaiva