OK well there you go, it seems to be out & legit?. There maybe...

OK well there you go, it seems to be out & legit?. There maybe more to the story yet. I guess watch this space. I do care about our trials foremost, but dilution is a thing for our MC also. It would be great to be out of TH tomorrow, just to see how things flow, but of course the standard is 2 days. I still think this will be a multi-input CR to cover us, including options.

Start-up for trial sites again in other jurisdictions including China & countries is the most expensive part for sponsors, we shouldn’t be surprised at all on this part, plus now we will have Paediatric patients on the trial, which is fantastic, because safety data has been continuous, otherwise the FDA would have said NO after DSMB review. They would have got the email, continue trial unchanged.

We have 94 patients enrolled (randomised) on the trial & for the “Intent to treat population”, the remainder out of that 144, we need Paediatrics (dependent on this positive outcome), patients in China & Malaysia & other countries. That totally makes sense, they continued recruiting, however allocation to each trial site has most likely already been worked out & done. Paediatric Rare Disease can also result in a large plus for the company…I don’t have a lot of time right at the moment, so maybe someone else may care to explain how this works with the FDA?