Replies to post #32555 on Biotech Values

[OKY]

Dew - Another great article

However because I don't understand medical implications I was wondering about the US (FDA) response. I did not see any new requirement just the ones already know, is this correct? I believe it was a restatement of what GTC already knew they had to prove.

That's, “We would really need assurance that the animals aren’t infected with any kind of prion disease,” and so on, the four conditions.

OKY Thank you in advance

[n4807g]

This is the paragraph that I found most telling:

"Although he won’t disagree, Louis Marie Houdebine, director of the animal gene study laboratory at the French Institute for Agronomy Research and a cofounder of BioProteins Therapeutics, suggests EMEA may have also been motivated to push an animal-derived transgenic protein through the regulatory process. “It’s possible that given ATryn’s low risk and infrequent use, EMEA chose to give an agreement that could have a significant impact on the development of processes to prepare recombinant pharmaceutical proteins,” he says. “They want good proteins and they hope the method will work.”

If the bias from the EMEA is towards hoping the method works as more drugs are evaluated and hopefully approved the process (method) will be looked upon as desireable.