Monday, January 01, 2024 8:55:59 PM
For the past couple of years, Northwest Bio has been almost exclusively focused on completing all of the prerequisites for the marketing application, but now that the application has been submitted, and is in the hands of the MHRA, Northwest Bio can catch their breath, bask in the glory of their accomplishment, while they wait for the application to be validated, (which is more than a few days btw) and then they will have to get right back to work.
Another significance of validation, or “official acceptance” of the application by the MHRA, is that when that occurs, Northwest Bio can finally turn their attention to other matters that have been in the periphery, such as; preparing for a commercial launch, re-engaging with NICE, preparing to file the application in other jurisdictions, finalizing new partnerships, preparing for new clinical trials, obtaining regulatory approval for the Flaskworks' system, and holding an annual shareholder meeting, just to name a few.
Once DCVax is approved, Northwest Bio is going to have a whole other set of tasks heaped on their plate, so yes, I think it actually does matter whether it takes 5, 6 or 7 months for approval, especially for a company that still has a tremendous amount of work to do, and has a history of missed timelines.
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