Regulatory: VasoDynamics is accepted for Parallel Scientific Advice Meeting with EMA-FDA
19th -November- 2025
VasoDynamics Ltd, the pharmaceutical company developing patient-friendly cost-effective therapies for the prevention/reduction of debilitating side-effects induced by anti-cancer treatments, is pleased to announce that, following successful Scientific Advice meetings with the Dutch Medicines Evaluation Board (MEB) and UK Medicines Healthcare Regulatory Agency (MHRA) earlier this year, the company will be undertaking Parallel Scientific Advice (PSA) meeting with the European Medicines Agency (EMA) and United States Food & Drug Administration (FDA) in early 2026.
Parallel Scientific Advice is a mechanism for EMA and FDA assessors to concurrently exchange with sponsors their views on scientific issues, particularly for medical products targeting unmet medical needs or for indications lacking guidelines. Such interactions aim to optimise product development especially at the close-to-market stage. The purpose of the meeting is to gain consensus on, and confirm, the phase 2-3 pivotal trial design and the pathway to market approval for the product Muc1 (NG11-2) through the PSA meetings. Muc1(NG11-2) is an oral topical pharmaceutical product designed to prevent/reduce severe oral mucositis induced by radiotherapy, a debilitating condition suffered by patients with head and neck cancer undergoing (chemo)radiotherapy.
Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:
“We are delighted to have been accepted for PSA and look forward to meeting with EMA & FDA in early 2026. The number of products which have been successfully accepted for PSA is typically around 4-5 per year, we appreciate the recognition of our preventive drug product NG11-2 by EMA-FDA and we look forward to achieving the optimal development and market access path to tackle the severe oral mucositis condition suffered by patients with head and neck cancer undergoing (chemo)radiotherapy.”
For enquiries, please contact:
Dr Ningfeng Fiona Li, CEO fiona.li@vasodynamics.co.uk
VasoDynamics is a clinical-stage pharmaceutical development company based in Stevenage-London, UK, with the vision to improve the standard of cancer care globally. Recognising the mounting cost pressures facing healthcare payers all over the world, the company is developing a portfolio of cost-effective, preventive medicines, which target debilitating and often dose-limiting complications of cancer therapy, such as chemotherapy and radiotherapy induced mucositis, dermatitis, and hair-loss. The company’s proprietary technology platform utilises the different dynamics of normal vs. cancerous vasculature, enabling targeted protection of normal tissue without disrupting the efficacy of anti-cancer treatment.