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manibiotech

10/13/23 7:41 AM

#640087 RE: flipper44 #640082

You are giving way too much credit to NWBO. Simplest answer is usually the right one i.e. they have submitted yet
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flipper44

10/13/23 7:44 AM

#640088 RE: flipper44 #640082

So. I think this (below) would indirectly suggest, NWBO could “handle” approval at the end of the year, and they could choose their own launch date.


An MHRA (Medicines and Healthcare products Regulatory Agency) approval indicates that a biologic has met the necessary standards for safety, quality, and efficacy. However, the timing of marketing the product post-approval is typically at the discretion of the company. Companies may choose to initiate marketing efforts immediately or delay them for strategic, logistical, or other business-related reasons.
— ChatGPT

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Springbok80

10/13/23 8:36 AM

#640134 RE: flipper44 #640082

My personal opinion...they want approval before end of year, they will get approval before end of year, and yes they can handle approval before end of year. Approval, impo will come much sooner than anyone expects. They have a great relationship with MHRA, one only needs to view all the history over the past 10 years to know that. MHRA truly appreciates the Fact that NWBO and it's management have been on the ball, and have been in regular contact with MHRA , keeping them updated and ensuring that they are responding to MHRA's suggestions and requests. This all leads me to believe that MHRA, will accept and approve in short order...my timeframe, and only my timeframe, MAA acceptance could be announced any day, once it is, approval within 30 to 45 days..."there goes that song again". Again, just my personal opinion.