But yet focus on the real truth, NWBO.
The JAMA Oncology indicated that the data was in fact true and legitimate, and we all know this to be true. In addition, we all know that the OS data was also better than expected.
Last, we all know that there are more doctors, scientists, and professionals are in agreement that the data is true and worth for NWBO to go forward. This is further proof that DCVax-L works and should be approved soon, weeks not months or years. All the best!
Just a personal opinion,
"But yet there was no identification of the significant bias int he screeners, the dosings, the statistical manipulation -- none addressed in the manuscript they reviewed. But clearly identified in the significant comment attached to the article and the Journal of Neuro-Oncology that published a detailed criticism. Regulators will see it clearly, especially the deficiencies in using post hoc protocol, external comparator selection, OS confounding, among others."
Just another personal opinion,
"Since NWBO hasn't completed any regulatory applications and filings, DCVax-L will be unlikely to have a decision until 2024. MHRA takes 150 days, FDA will be standardly 12 months. Hope you're patient."
I have worked with multiple regulatory agencies for over 30 years, they have the ability to change their timelines for approvals at their discretion. Based on the current performance factors for DCVax-L, the probability for approval should occur before 2024, several months after manufacturing approval. The manufacturing efforts are going well and should be approved soon in a matter of a few months and could happen in less time than that, IMPO.
All the best!
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