Alstrom NewsToday's news is very positive. The PIM means that regulatory authorities are increasingly convinced of 4050's potential to be an efficient treatment for this most difficult of diseases. The next step in the EAMs process is for PLI to obtain a scientific opinion from the MHRA, which hopefully will provide additional 3rd party validation https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams.
If 4050 gets into the EAMS program, I wouldn't be surprised to see 4050 approved for Alstrom in the UK sometime in H2 2018. This is based on the following :
EAMS Period:This is the period between a positive EAMS
Scientific Opinion and the Marketing Authorisation. The duration of this stage is expected to be around 12-18 months.
There will be little immediate commercial benefit to PL as 'The
EAMS medicines will be provided to the NHS free of charge by the company during the EAMS period.
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/520967/eams-operational-guidance.pdf