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I think certain approvals are required for Phase 3 trials, not sure we or the outsourced pharmas have them or not, phase 3 trials have a component that tests long term safety so it cannot be rushed, min 1 year, in the scale of a new drug that is in sight of the finish line I guess. If it is to be sold then I would expect offers well before completion of phase 3, otherwise very few could afford it, presuming all goes well with phase 3 !
The date of the publication was 10 March and there were RNSs on the matter in March
i think you need the electric hat, GL
But do we know anything about a Phase 3 trial? How much would that cost?
When could it start and how long would it take to conduct, analyse the results and get formal approval? 12 months or more? Are we getting ahead of ourselves? Hope someone who knows about these things can put my hat straight.
I can see now why CF said monetisation of IMUTEX will be at least 3 months away!
That is the time it would take for them to complete a phase 3 challenge study for IMUTEX FLU-v.
Gosh if phase 3 is successful then the price tag for IMUTEX will be top dollar. Quote CF: “100m to 500m"!
What a one-off cash dividend win fall that would be.
Here is what the latest ScienceAlert published 30th May had to say about FLU-v
“3. A potential universal flu vaccine has passed an important set of clinical trials
The virus strains that cause influenza are shapeshifters, constantly moving beyond our ability to immunise against them - hence, we need annual flu shots to stay ahead of the disease. A 'universal' flu vaccine would give us a huge advantage in this race, and there's now a truly promising candidate on the cards.
The vaccine, called FLU-v, has successfully passed phase I and phase II clinical trials, demonstrating its safety in human subjects; it's been found to induce immune responses that last at least six months. We can't wait to see the results of the next phase of trials.”
https://www.sciencealert.com/can-t-deal-with-the-news-here-are-10-hopeful-stories-you-need-right-now/amp
'ScienceAlert' article dated today, look what gets mentioned at no.3 - 'Flu-v'.
They are excited for a P3 happening and so should we, but perhaps perhaps for other reasons.
https://www.sciencealert.com/can-t-deal-with-the-news-here-are-10-hopeful-stories-you-need-right-now/amp