Biotech Values

[Biowatch]

GTCB - I still do not understand why GTCB apparently only just found out that the pregnant patients could not be included in the evaluable patient data base subject to review in the clinical trial, and if they did not count, or could not count, why this issue was not raised in advance.

And yes, if GTCB is going to get blind-sided like this by the FDA, they better find out now.

As I mentioned previously, it's a lot easier to figure out when you are pregnant than to know when you will need surgery, so it is presumably easier to recruit pregnant patients than surgical patients for these trials.

If they have to get separate approval for pregnant patients with this extremely rare disease and for surgical patients with this extremely rare disease, then it seems like a miniscule market, even if it saves lives and, in the case of pregnant patients, leads to healthy children without the disease.