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

Monday, April 20, 2026 - Week 17CURE 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.pdfPetition: 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.pdfReuters 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-3666-0001Paragraph 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=ACoAAAAD8f4B7JC4TMss45Q8hrsq5kiceI0Z8HEPress Release cureSYNGAP1.org/PR45US, use your ICD-10, F78.A1: https://onlinelibrary.wiley.com/doi/10.1002/epi.70142Study list!Citizen Health https://www.citizen.health/ai-advocate/syngap1Combined 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 $265K last year; this year, we have 20+ teams!https://curesyngap1.org/calendar/sprint4syngap-2026Thank your Rifton for the donation of the tricycle.Email today: https://mailchi.mp/curesyngap1.org/sprint-for-syngap-2026-one-community-one-goal?e=17610baa03INAUGURAL SF NIGHT OF IMPACT, CA – 38 daysJoin us this is our only Gala for 2026!cureSYNGAP1.org/SF265TH SCRAMBLE FOR SYNGAP, SC – 166 days Classic case of a small event becoming an institution!cureSYNGAP1.org/Scramble26PUBMEDPubmed 2026 is at 26. +9 vs the week. (61 last year was +9) https://pubmed.ncbi.nlm.nih.gov/?term=syngap1&filter=years.2026-2026&sort=dateSOCIAL MATTERS4,891 LinkedIn.  https://www.linkedin.com/company/curesyngap11.55k YouTube.  https://www.youtube.com/@CureSYNGAP111.1k Twitter https://twitter.com/cureSYNGAP145k Insta https://www.instagram.com/curesyngap1$CAMP closed at $4.67 Friday.https://www.google.com/finance/beta/quote/CAMP:NASDAQLike and subscribe to this podcast wherever you listen.  https://curesyngap1.org/podcasts/syngap10Episode 205 of #Syngap10 #CureSYNGAP1 #Podcast