IMO anything by anyone that is a step forward for MND is a great achievement.
Like cancer in dogs, we ‘could’ see far better results in an approach that has a co-therapy for some patients where MPL is a part of that solution. Who knows.
I also don’t feel that the world should wait for MPL to get out of the Phase 3 gates. It is up to the PharmAust to move as quickly as they can given all of the constraints, of which there are many.
Now, here is a thought. We are just weeks away from cohort 2. A couple of months away from cohort 3, we may or may not need cohort 4 but even if we do, just a couple more months to cohort 4 completion.
All the while, I am confident that preps to go to next phase design and preps for approval are underway to minimise delay between the current Ph1/2 and next phase.
I am assuming we need to move to a formal Phase 2 to complete any gaps. Not actually sure..
I am also expecting that any good results will be supported by Fight MND to progress with a further submission at the appropriate time. It may also trigger opportunities with others to support the advancement. Remember, the IP (underpinning value being generated) remains 100% with PharmAust.
Now have a look at the global media that have been red hot with the latest drug advancement. The world is interested and often personally invested in fighting MND (think ice bucket challenge)… We have the potential to be entering that global news worthy category within months. Right now we are in the almost unknown category but entering the observed/watch list, with cohort data it could be very interesting (this is only weeks and months away), completed phase 2 with good results could be fascinating and likely compelling news. With some good results on MND management, this little company wouldn’t know what hit it. Not suggesting we will rocket to $$$ but I would expect a solid re-rate. Won’t complain if we do rocket all the same.
For the long timers, we have waited and gone on the roller coaster watching our investment rise and fall with all the frustration that comes with it. We have suffered the delays upon delays and trials running significantly longer than anyone anticipated.
Hope we can all cope with a trial moving at pace as this one seems to have found its rhythm. Not saying the SP won’t have a few more wobbles but the news will get out as people come back from holidays I reckon and as the results land and get communicated.
Even though most of us were/are highly confident that the drug would be safe and well tolerated, it remained a real risk and, to me, one of the highest hurdles to get passed in this trial. It represents the highest risk in enabling all future human trials for all uses. My confidence in seeing the hurdle in the rear view mirror is now at 98%. The data from cohort 1 will deal with the last 2 %
I think we are in a very transformative and pivotal position.
adreamer
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