Given that fact that DCVax-L data results have already been reviewed and evaluated by multiple creditable sources there is a high probability of sucess as the data already indicates this to be true. Therefore, it appears that you are putting the horse before the cart. In other words, the probability of approval from the MHRA is very high. However, approval without the ability to manufacture a successful vaccine is worthless since there is no meaningful way to meet the product demand objectives after approval is granted. The Sawston, UK facility has spent considerable time and effort with their initial manufacturing process method, and now with their latest manufacturing method utilizing the Flaskworks devices. For more details, refer to the following link.
"Undoubtedly, efforts have been taken to facilitate discussions between different stakeholders at different levels in order to ensure accessibility to promising new technologies in a timely manner but ultimately it is the companies’ responsibility to price their products responsibly and work with NICE and NHS England to ensure timely access for patients to promising technologies associated with significant benefits." Clearly stated by NICE, you cannot ensure timely access for patents unless you already have implemented the means to provide the product to market and the patients. This supports the fact that if you receive approval and no means to provide the product, the patients will have to wait a considerable amount of time, years and many patients will die as a result of manufacturing delays.
Since the Sawston, UK and NWBO have already invested considerable effort in manufacturing readiness, it would make sense that approvals would be in order sooner rather than later. All the best!
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