Comment on Haystack Petition to FDA. New Board of Trustees. #ICD10 F78.A1 #CureID #S10e205

Monday, April 20, 2026 - Week 17   CURE SYNGAP1 joins the Haystack Project in petitioning FDA for more clarity. PR: https://static1.squarespace.com/static/5966cc2220099e91326caaec/t/69d7dbb80155f46e144ae2e5/1775754168227/4.9.26+press+release+petition_vf.pdf Petition: https://static1.squarespace.com/static/5966cc2220099e91326caaec/t/69d7e016d5986e16ff09b64c/1775755288463/Letter+Head+Petition+for+rulemaking+to+amend%C2%A021+CFR+%C2%A7+314.126+and+%C2%A0%C2%A7312.47+%281%29.pdf Reuters 4/1: https://www.reuters.com/sustainability/boards-policy-regulation/rare-disease-advocacy-group-urges-trump-administration-restore-fda-clarity-2026-04-01/ Pink Sheet: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/could-structured-not-ad-hoc-us-fda-flexibility-increase-rare-disease-development-certainty-BYXJENIJLFEINOSO72RS53ZJHE/   Show your support here: https://www.regulations.gov/document/FDA-2026-P-3666-0001 Paragraph 1 – Share information about you and SYNGAP1. Paragraph 2 – Seizures are hard to count while X, Y and Z are major burdens but FDA wants nice countable seizures, this makes it hard to develop drugs. Paragraph 3 – How could “clinically meaningful” endpoints potentially help your community and drug developers? How could a study design other than a ‘randomized clinical trial’ help? How could FDA consulting with disease-specific experts help? Closing  – Finish your letter with anything along these lines: We support the framework for all rare set diseases in Haystack’s petition. We don’t believe FDA has to lower the evidentiary bar to approve treatments for our diseases. Randomization isn’t always possible. New scientific methods should be considered. Endpoints specific to our disease should be considered. We urge FDA to open a rulemaking so we can have a legally binding regulation.   Board changes, thank you to everyone. https://www.linkedin.com/posts/curesyngap1_curesyngap1-syngap1-patientadvocacy-activity-7450528611339616256-4MJF?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAD8f4B7JC4TMss45Q8hrsq5kiceI0Z8HE Press Release cureSYNGAP1.org/PR45   US, use your ICD-10, F78.A1: https://onlinelibrary.wiley.com/doi/10.1002/epi.70142   Study list! Citizen Health https://www.citizen.health/ai-advocate/syngap1 Combined Brain (May 1 & 2 in NorCal), https://docs.google.com/presentation/d/1IjaHILXj7AlBDlbTJgvYrkBS_0bnI8VCnTIiPXJ7JGM/edit?usp=sharing  ProMMiS https://www.linkedin.com/feed/update/urn:li:activity:7450196488300728320  Rare-X, the same week. DSC and Cook’s are coming soon! CURE-ID for Drug responses.   CURE-ID is cool. https://cure.ncats.io/home (Webinar coming) Webinar: Thu May 7, 2026 1:30pm – 3pm (PDT) cureSYNGAP1.org/cureID    6th ANNUAL SPRINT FOR SYNGAP1, EVERYWHERE – 5 days - $207k! Go Tavilla. 17 teams raised $265K last year; this year, we have 20+ teams! https://curesyngap1.org/calendar/sprint4syngap-2026 Thank your Rifton for the donation of the tricycle. Email today: https://mailchi.mp/curesyngap1.org/sprint-for-syngap-2026-one-community-one-goal?e=17610baa03   INAUGURAL SF NIGHT OF IMPACT, CA – 38 days Join us this is our only Gala for 2026! cureSYNGAP1.org/SF26   5TH SCRAMBLE FOR SYNGAP, SC – 166 days  Classic case of a small event becoming an institution! cureSYNGAP1.org/Scramble26 PUBMED Pubmed 2026 is at 26. +9 vs the week. (61 last year was +9) https://pubmed.ncbi.nlm.nih.gov/?term=syngap1&filter=years.2026-2026&sort=date   SOCIAL MATTERS 4,891 LinkedIn.  https://www.linkedin.com/company/curesyngap1 1.55k YouTube.  https://www.youtube.com/@CureSYNGAP1 11.1k Twitter https://twitter.com/cureSYNGAP1 45k Insta https://www.instagram.com/curesyngap1   $CAMP closed at $4.67 Friday. https://www.google.com/finance/beta/quote/CAMP:NASDAQ   Like and subscribe to this podcast wherever you listen.  https://curesyngap1.org/podcasts/syngap10 Episode 205 of #Syngap10 #CureSYNGAP1 #Podcast