Study review and next steps
As outlined in the recent announcement, the vehicle response seen with all US sites was unusually
two to four times higher than that seen in Australia, for both inflammatory and non-inflammatory
lesion reduction measures respectively.
The Company is confident that the execution of the study
protocol was consistent across geographies and within geographies, whereas the manufacturing and
Phase 2 study supply was the key differences between the geographies.
Botanix is actively
investigating the reasons for this unusual US response and is working with external experts in both
clinical management and manufacturing to review the study conduct, operations and materials.Since commencing the Phase 2 Study, optimisation of the manufacturing scale and emergence of
commercial suppliers of synthetic CBD have supported improvements in the process. These changes
ensure the manufacturing process is scaled up with consistent equipment and simplified processes.
Botanix has now secured a consistent supply of CBD (recently announced an agreement with Purisys
the world’s largest and most experienced synthetic CBD manufacturer) and PermetrexTM (from a
global specialty chemicals company with a presence in 70 countries).
Following finalisation and review of the Phase 2 Study data, the Company is planning an end-of-Phase
2 meeting with the US FDA. Design of the Phase 3 program and timing
will be reviewed by Botanix in
consultation with the Company’s key opinion leaders and clinical trial investigators based on the
powering and other study conduct data drawn from the Phase 2 Study.
There was more on a Twitter feed or one of the Social Media outlets,,, which identified BOT were taking the discrepancy seriously and were seeking independent answers.... may have been a comment fro Vince....
The key take away from all of this is,,, Moving on to Phase III ,,, No Adverse Trial Patient Effects caused directly by the product.
The other is the cream did not burn, was not sticky and when rubbed into the skin left no residue... eg whiting . paling ..
It does seem to me IMHO that the company are not gut f*%%* disappointed , the results allow BOT to move forward , sure we would have liked a clean sweep , but refinement can continue , although it would seem no refinement required for the Australian results..
If BOT wanted to spike the SP ( which they dont usually ) they could release more data on the Anti Microbial and Anti Bacterial sanitizer ... that in itself could be a Billion Dollar product,,, that BOT have pulled the ladder up behind themselves with , the % solution is key and BOT have that in the bag....
Again I believe we are in for a flurry of News,,,, Biotechs are notorious for Potential Value ,,ie they are working away in the back ground and Value is stored until they make an announcement ... BOT are working on at least 3 other fronts/treatments that news flow has not been reflective of progress,, when that news comes to market it catapults the SP and MC upward..
Similar to the band that play for a decade in pubs and clubs to then to have a number one and everyone thinks they are an overnight success ...
Those that know me know i would drop a share with a 10% backward step,, I preserve capital ,,,, in BOT's case I have not sold a single share....why because they are not a one trick pony.... more a Team of Clydesdales
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