Ann: Chairman's Address to Shareholders, page-24

Treagus' most interesting comments to me were in the Q&A session that followed the AGM in response to a question about why the FDA refused breakthrough designation.

Firstly he stated that the reason they were denied was because the results weren't strong enough statistically to convince the FDA, even though the chances of a false positive were only 2.3%. A limited number of participants, split between drug and placebo, those on the drug split between 35mg and 70mg, meant the results of the key group (70mg) were considered not statistically robust.

Secondly, he mentioned that NEU had yet to determine whether the results should be unblinded and this would be determined after the next meeting with the FDA. The reasoning behind this is that it is felt that the number of potential participants in a future trial might be negatively impacted if parents are aware of whether their daughters were on the drug or placebo in the phase 2 trial. NEU wants to have further discussions around this point as well as identifying what the FDA expects from them as the next step in the process.

Thirdly, he gave a very strong hint that NEU would be looking for another opportunity to resubmit for breakthrough designation if they can overcome the reason for the original knockback.

While I agree with the poster above who reported Treagus' comment on 2591 as it "was bubbling along in the background", he did make the point very strongly that the vast majority of resources are being directed into trofentide and that time and speed to market were the key outcomes they were seeking to achieve.

I was neither overly excited or disappointed in the meeting - it appears the company is in a bit of a lull with the next two phase 2 results not due until Q4 and the next step forward with the most immediate prospect (Rett) stalled somewhat until the next meeting with the FDA.

Happy to be corrected by other attendees as I'm only relying on my memory of what was stated.