Biotech Values

[DewDiligence]

>Might be we as investors need to take a part of the blame not to realise the trial size risk and design and also the small redflags on the way?<

GTC received protocol assistance from the EMEA in designing the pivotal trial, which is roughly analogous to having an SPA in the U.S. The EMEA’s request was for 12 patients, so the small number of patients per se was not a risk element. The problem is that GTC did not follow the dosing protocol to the letter on the pregnancy patients, which led to the pregnancy patients being excluded from consideration. However, there was no “red flag” for investors on this matter because the protocol change was not disclosed to investors.