Member Info for Grace83

Ok, this is my first post, but I’ve been invested and following this share for a while. I’m hoping that the wording is just Eton being cautious, whilst quietly confident, with nothing being a foregone conclusion with the FDA? I can’t see that there’s anything for them to have a problem with, regarding Alkindi, as it’s just a different way of administering hydrocortisone to infants in a safer manner. It’s In the form of pre measured capsules that taste better than the standard treatment (which currently has to be mixed by a pharmacist ,leading to Possible dosing inaccuracies, so is clearly currently a highly inefficient way of administering hydrocortisone).

For me, Chronocort was a whole different ball game, as the primary endpoints for the phase 3 trial were incredibly vague for me, as a scientist. This has since been more than satisfied, by changing the endpoints, with Chronocort showing detailed benefits over the current standard treatment. Especially since the longer term benefits were then studied, of a marked reduction in steroid use, better management of androgen 17-ohp, fewer sick days, along with other unexpected benefits. So I completely agree, it only failed the phase three on statistics and technicalities, which have now been amended.
I’d appreciate Any thoughts on this, for people that have been here longer than me?