Interesting Bell Potter thoughts...

I found this very interesting perspective from BP, especially the bit about FDA's Bill Dunn resigning, they updated their report on Neuren on March 3 they also maintained their $8.60 Valuation
GLTA

"When we consider the probability of an FDA approval of trofinetide for the treatment of Rett syndrome (PDUFA action date of March 12), it is worth looking at recent new drug applications for similar rare neurological diseases.Only this week, one such drug was approved by the neuroscience review team at the FDA.On Tuesday 28th Feb, the FDA approved a New Drug Application (NDA) for ReataPharmaceutical’s omaveloxolone. This comes after a turbulent few months in the lead-up to Tuesday’s (Washington DC, US time) final PDUFA action date for omaveloxolone, as a treatment for patients with Friedreich’s ataxia (FA). FA is a rare, neurological disease thatcauses progressive damage to the brain, nervous system, and muscles.While not a cure, the drug known as Skyclarys (omaveloxolone), will cost US$370,000 annually, and may slow the progression of this debilitating disease that begins in late childhood and affects about 6,000 Americans and 22,000 individuals globally.Reata pharmaceuticals (RETA) has struggled to get drugs across the finish line in the past.And omaveloxolone wasn’t a walk in the park either. By the company’s own admission,FDA staff conducting the review raised concerns about the strength of evidence supporting omaveloxolone efficacy as a treatment for FA.The single clinical trial, completed nearly three and half years ago, showed statistically significant improvement in neurologic function compared to a placebo. However, during the course of the review, FDA staff informed Reata that the results were “not exceptionally persuasive,” with “weak support” from supportive analyses – ie, concerns about the clinical efficacy.On Monday 27th, one day before the final decision was announced, the FDA's head of neuroscience, Billy Dunn, announced he will be resigning from his post, and Reata’s stockprice dropped by >30%. And yet, the very next day, when the final nod was given, RETA stock soared 198.9% from US$31 up to $93.17. RETA stock has been trading around the US$86 mark since the initial rally following the announcement.Just like trofinetide, omaveloxolone had received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA.It is also likely that Bill Dunn has been involved in the review of trofinetide, given the reviewhas been underway for the past 6 months. Mr Dunn was pivotal in the agency’s decisionsto approve controversial anti-amyloid antibody, aducanuymab, in late 2021, and more recently with a treatment for ALS made by Amylyx Pharmaceuticals. This all bodes well for Neuren (and US partner, Acadia), in the quest to have trofinetide approved for use in children with Rett syndrome."