Hi OC - a good question.
The take out for me was that the path to market does NOT hinge on the 18 from 46 dogs achieving SD - the marketable product or 'niche' is the extension to survival + high quality of life + safe to use + no side effetcs + low cost. All of this appears to occur REGARDLESS of whether the dog has PD or SD at day 28 under the current trial protocol.
To be clear, we are in relatively uncharted territory here as previously SD has been associated with longer survival times and better outcomes, while PD is associated with less positive outcomes. MPL appears to be challenging this paradigm.
The extension of survival x3 or x4 while enjoying high quality of life and no nasty side effects in an affordable take-at-home tablet IS the line of site to market. Clarification (validation) of what we have discovered - almost by accident - is what the phase 3 will do. Looking at the data and even acknowledging its retrospective nature and consequent limitations, the outcome is stellar and presents an incredible opportunity for potential development partners.
The big bonus is the safety profile - it's known to be safe so there's little downside to 'giving it a try' with current single-agent chemotherapeutics to gauge efficacy.I hope this addresses your question.
Cheers
Densy
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Hi OC - a good question.The take out for me was that the path to...
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