Let me summarise my take on the recent trial. NCT05933525, did not meet the primary endpoint, in anyones language it was a failure.
The following is my hypothesis only. I can guarantee it is not 100% correct as I don't have all the facts but this is what I can surmise given the limited info fed to the market over the years. I am not going to debate the why's and how's but am simply presenting some facts.
The P value is a glowing red light of failure for trial NCT05933525.
Does this matter? maybe not because here is what good/remarkable results look like.
Reported in 2011.
Remember primary endpoints are slightly different between the data. Numerous other in-vitro/preclinical data since has been collected supporting the data below.
So why even do NCT05933525? The DoD does not like the three dosing regime it is impractical, an attempt to provide data on a single dose was made it failed to meet the primary endpoint. Yes secondary data points were good, but for my mind irrelevant to the DoD. The DoD require a compound that keeps their killing machines in the field doing what they do best. Do they care about hospitalisation/mortality rates? not really because throughout the
majority of the world with basic care travellers diarrhea does not kill you, as per before the DoD need the minimum number of killing machines being taken out of action even for that basic care, they have been attempting to find a compound for many many years to provide this protection and IMC are most certainly not the first or prob. even the last to be explored.
So where to from here? NCT04605783. A two dosing regime being run by the DoD itself, this
is the pivotal trial. If it provides good/great results, can the DoD accept a two dosing regime? The billion dollar question? (possibly literally, if the company has implemented solid commercial agreements). If the two dose regime is a bust, or, if the two dose regime is unacceptable I believe the DoD collaboration, at least for this compound, will be over.
Does this even matter? Maybe, maybe not. So many questions present themselves if the DoD drop future collaboration re. IMM124E. This is the answers will will have soon enough I believe. In fact may not even be that bad, again dependant on what agreements have been made by previous management.
My take on the way I read the recent company info is irrespective of the DoD's future involvement IMC will move to Ph3 trials I imagine on a three dosing regime unless the NCT04605783 data is good. Time will tell.
Re. ones individual opinions/questions moving forward if the DoD cut ties....DYOR. Please DYOR... mindless, incessant ramping via one liners does my f....
head in. (finally had to say it). Just block me if facts bore you. I'm happy to debate my interpretation, as I said it is just my hypothesis.
The one fact is moving forward with FDA approvals etc. will be costly, take a very long time and will need to be extremely well managed. Without a single doubt in my mind the company has been extremely poorly managed in the past. I don't believe a single person, not even Roger himself, could honestly argue that fact.
Only the future will tell if this can/is/will change.
(20min delay)