TVP, thx much for your MHRA/NICE analyses, very informative. Yes, companies do not tend to divulge much info on regulatory discussions/detailed steps unless they significantly negatively affect timelines which may result in a legal responsibility to divulge to investors. To do so when not legally bound to is a lose/lose situation for both the sponsoring company, who opens themselves up to potential lawsuits which claim the company inferred successful interactions, and for the RA who may be deluged with pressuring contacts from consumers and patient groups, both of which may be quite unnecessary at that time. The regulatory process is fluid and investors never know the level of interaction that occurred, particularly when there is a special designation such as an orphan drug or PIM.
Benefit such as elongation of OS devoid of debilitating or high risk mortality side effects is exactly what NICE looks for regarding lethal disease states such as cancer.
MHRA working off its MAA review backlog is just the latest and apparently last obstacle being overcome to bring DCVax-L to the market.
GLTA
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