Replies to post #6806 on GTC Biotherapeutics (fka GTCB)

[croumagnon]

"Bad Data is extremely unlikely."

Yes, based on the EU studies and the fact that ATryn being a recombinant drug should not behave worse than a plasma derived drug. However, with such few patients in the trials (I believe 14 in the EU and 37 in total) anything could happen as any statistician would tell you. The sample size is so small that one or two patients with unlucky outcomes could skew the results dramatically one way or another. So, while I still think the results will be good (90% chance) there is still a possibility of bad luck in such a small sample size that we can not totally dismiss...

The big question that I tried to bring up before is: even if the data is not that good and US ATyn is a no go, will the stock still take a further beating or are we already priced for such a failure? My own thinking is that we are already nearly priced for such a failure...

[RufusT]

"The FDA with is unforgivable delays in reviewing drugs, is way overdue for reform"

AMEN! By all accounts the FDA had a record year of delaying and hedging and wallowing in indecision. The likes of Kennedy and Grassley had no small hand in this lethargy but the FDA didn't need any help. An agency that regulates such a large part of our economy (one quarter by some accounts)should be thinking of ways of cooperating with industry rather than being a roadblock. As Commissioner Alexander Schmidt said back in 1974:


In all of DA’s history, I am unable to find a single instance where a Congressional
committee investigated the failure of FDA to approve a new drug. But, the times when
hearings have been held to criticize our approval of new drugs have been so frequent that
we aren’t able to count them . . . The message to FDA staff could not be clearer. Whenever a controversy over a new drug is resolved by its approval, the Agency and the individuals involved likely will be investigated. Whenever such a drug is disapproved, no inquiry will be made