SH Block and List of Questions, page-64

I agree. From my understanding ( I may be wrong however), the meeting in May should give us the requirements for the study for the pharmacological agent. The critical thing will be the timelines and what type of studies are required. This is aimed to get a positive scientific opinion with the EMA and finally a CE mark with the BSI.
Our application for a CE mark has not been withdrawn from the BSI (but they will not give a positive opinion without a positive SO from the EMA). So I think we still want a positive SO (hence the May meeting).

From the website:"
Scientific advice is when the Agency gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
Companies can request scientific advice from the European Medicines Agency at any stage of development of a medicine, whether the medicine is eligible for the centralised authorisation procedure or not.
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency’s advice increases the probability of a positive outcome."

So my take is that we are almost there. And with the SAWP meeting in May - timelines can be considered and hopefully progress to getting the CE mark with a positive SO (which is much more likely based on the website advice for the SAWP in the last sentence).

All IMO