Companies can call their studies any phase they want but 1b makes the most sense. I still consider the A273 AD study to be a phase 1b with a long OLE as there was no control group (Biogen's aducanumab study had > 100 patients with placebo followed by long OLE with efficacy data and they called it phase 1b). I think 15 patients and 7 weeks is too small to try to get any meaningful data and extending it as official monitored visits (instead of just free drug) would add costs.
Unfortunately, pain and dizziness are very subjective and poor communications makes it even more challenging. I assume most Rett parents have figured out how to know when something is wrong and this info will be passed along to the coordinators. Studies use the CTCAE criteria to grade adverse events as 1 (mild) 2 (moderate) 3 (severe) 4 (life threatening) and 5 (death). Grade 1's and 2's are very common, even in placebo groups
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