Replies to post #10338 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Pros and cons of an FDA advisory panel

>...there is potential for people to talk about goat genes invading humans etc.<

That’s why I would rather not have an advisory panel, where the mike will be open to people who want to express all kinds of wild and crazy viewpoints about transgenics.

>I still think an advisory panel is more positive than negative because of the strong data. I would think the opposite if data were weak because the usual setup for the FDA has been to murder biotechs with weak data using advisory panels.<

I disagree strongly. In general, weak data imply that you want a panel because it’s the best chance to pull a rabbit out of the hat, while strong data imply that you do not want a panel because it’s better to let sleeping dogs lie. Regards, Dew

[quantumdot]

re GTC's strong data. you are both using the term "strong data" to defend your views on the likelihood of an advisory panel for ATryn. My only caution is that although the data points they have are good (safety, equivalence etc.,) they are very few in number. I know this is in a very small patient population and larger trials were not commercially feasible.

However, IMO, it is precisely because it is a new technology and because the number of data points is so few that the FDA may ask for an advisory panel. If this happens, I agree with Dew that it would not be good as it will inevitably provide a forum for a discussion of the social acceptance of transgenic pharmaceuticals. Exactly what GTC does not need!