@Badvet73
worth a read Post #: 58793372
from that schedule consider the size of the addressable market globally .....just mindmed stealing a run ? short term spot price maybe great news of course.....but not reflective of sector achievement as a whole
perhaps consider how they might address the path forward with the following in mind:
there are many companies, as we know, who like to raise private placements and keep the lights burning for another 12 months - the medicinal cannabis sector is full of such activity ...I predict the psychedelic sector will be fairly similar should rescheduling occur....that will do a couple of things which is a commercial reality.....it will pull research investment and development capital away from genuine pharmaceutical drug development and create a 'double sector' if you will -
what cost a late stage psychedelic clinical trial wiith restricted availability of funding ?
= USD 20 million minimum ....(current cost)
further current financials:
Stage 1 therapeutic clinical trial USD 4 million
Stage 2 therapeutic clinical trial USD 13/14 million
Stage 3 therapeutic clinical trial USD 20 million
pivotal phase 3 clinical studies for new drug approvals by the FDA cost per patient on average USD $41,000.00 each
total approx - $38 million across the number of years needed to execute those trials - if they are successful of course.
add to that any/all pre clinicals and its a 'gettable' number ......lot of stars need to align - management and financial strategic pathway is key....as I've tried to highlight.....for simply one drug development in psychedics.
if any of those trails is not successful double the cost allocation and double the projected timeline at a minimum if the company concerned can even negotiate such a set back
its a situational reality if such a failure relates to a researched variable in the framework of a multi-variable study and that produces an outcome that is not statistically significant ( within the research context that is what is being sort) the development pathway will be significantly hindered both in time and additional cost to remedy the situation. ( think University of Queenslands' Covid vaccine development program where that statistical outcome was the complete opposite of what was intended - failed research program yet it appeared to be a winner right up to those proving human trials .....sadly it must be said - commercial reality )
Assume a successful outcome is achieved - what cost to then bring that drug to market? increasing drug prices factor in licensing, marketing, packaging, distribution etc
Patent cost on filing and defense if/where needed.....maintenance of those patents across their life...
So with all this as a reference point where is psilocybin / psilocin in the sector as an investor will look at it ?
would it be wise to have University research backing within the development framework? Yep ...it significantly reduces those research costs listed above - it also provides advantage to the sector generally....this is cost offset and key to success
the company will also require exceptional management team to negotiate the logistics and strategic company goals - backed by an exceptional medical research team and industry wide partnerships......(founder/company isolate syndrome is a very common pathway failure benchmark....Im sure everyone is registering that within their own investment history....happens all to frequently)
finally cos this post is way too long....
How many trials globally investigating the use of psychedelics to achieve potentially establish the framework for 'standard of mental healthcare' since 2000?
320 clinical trials is the number. astonishing hey
Are then any phase 1 or 2 trials currently underway examining the use of psilocybin for mental health treatments?
phase 1 = 38 phase 2 = 26
another interesting fact...9th Nov 2021
Compass conducted the largest randomised controlled double blind with psilocybin....
Incannex have selected the right psychedelic, the right trial and the the Uni / team /lead investigator and BOD imo = excellent risk mitigation going forward
another viewpoint for sure - relevance - up to each of us as investors - speculators have a completely different agenda
