"i put to you onyx, what if the trial shows ordinary results? i also put to you that medical science of this type (of any for that matter) is not done and dusted as many are suggesting here. yes the uptake by the pharma was quick to be realised but so is there the 'desperation' for treatment not just the human aspect but the $ aspect thereof."
If the trialwith Onyx shows ordinary results it really has very little impact on PAT-SM6 - this trial is just to show how they work TOGETHER in COMBINATION.
On it's own while yes they are relatively mid stage results PhaseI/IIa but they have already shown stability in patients that have failed all other available treatment options and at a half dose with no safety issues unlike every other treatment option. Same story as Onyx outcome if Cohort 4 raises safety issues we already know that the half dose has been successful in delivering outcomes to patients where every other drug has failed to do so. If it fails to work in combination with carfilzomib there you go - but it doesn't detract from it's activity on it's own or in combination with others. Onyx is desperate to find something to lift profile though currently sitting as 3rd line treatment when it really wants be first line ahead of Takeda & Celgene.
It brings up an interesting question though has Onyx already been able to peep the 4th Cohort safety status or are they going to base the trial on the half dosage as already released with successful outcomes ?
While of course nothing is certain in drug development but it's worthy of looking at the statistics of Orphan Drugs that then go on to market and it is far more than the long line of other drugs that fail along the way. EMA & FDA approving ODD is a pretty heavy validation looking into the future.
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