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Northwest Biotherapeutics sees MAA submission mid to late November
The Fly

Northwest Biotherapeutics sees MAA submission mid to late November

orthwest Biotherapeutics provided an update about its progress toward submission of a marketing authorization application to the Medicines and Healthcare Products Regulatory Agency in the U.K. for commercial approval of the vompany’s DCVax-L treatment for glioblastoma. Northwest reported that the majority of the MAA has been completed, and all but one of the key sections of the MAA have been delivered to the publisher. “The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.” Northwest anticipates that the remaining section of the MAA package will be delivered to the publisher within about two weeks after the consultants return on October 30 after being temporarily unavailable during the next two-week period. With this timeline, the submission of the MAA to the MHRA would take place between mid and late November.

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