RE: Interesting week or two to follow.29 Jun 2024 16:08
Good afternoon HbD
Effectively phase 1 trials are about safety.
It can in certain circumstances consist of a 1a and 1b an overlap. The latter 1b in patients as proof of concept.
I would hazard a guess here that Sareum chose the 1a 2a for a reason
Firstly the debacle of MHRA and CTA.
Secondly of funding. I would reckon that with a budget and the ever declining status of funding and ability to obtain finance. This being that their presumption of we don't want heavy share dilution but we reckon we can attract a deal of somesort ie on licence to conserve outgoings.
You have in effect now phase 1 a which incorporates an overlap into phase 2 for proof of concept ie viable progression to potential treatment for Psoriasis with out the need for application snd associated costs and time involved for phase 2 trial.
The downside effectively you still are in phase1
Category.
By the progression into phase 2a trial you can limit the proof of efficacy into a handful of psoriasis patients who choose to participate. You are now a company that has the kudos and attention of pharma as you have now a Compound in phase 2.
The bucks go up.
You can also at later stage increase the amount of patients in the larger part of a 2b trial.
Again here additional costs running into the 5 to 15 million pound arena subject to number of participants of course.
This is an approx figure of 40k cost of patient as a part 2b
100 to 300 patients.
It will not be far out.
Whilst you are in phase 2 at early stage 20 or so patients you are looking at smaller number but will give an indication of proof of concept albeit for statistical analysis this number is on the very low side. Statistics are much more accurate with higher numbers.
The higher the count the more accurate level of success ( and events) can be applied especially to allow a credible confidence factor.
So hence l feel the intent of Sareum was to conserve funding which can appear good also prove very risky. Many companies fail not because their products or services are no good but lack of finance and that requires business acumen.
You must expects the best prepare for the worst and have a plan or plans in the event that the worst happens. That means thinking ahead, way way ahead and that includes world wide events not just your present little what you perceive safe cocoon around your company or the goldfish bowl you are looking out of.
Communications of utmost importance.
Scientists are certainly not the best in this area by far.
You need a bullet proof fortress around you in a project of any sort, that being thinking ahead xnd perceiving and having plans in place for any problems that can however unlikely in an effort to nigh guarantee success.
The war in Ukraine has caused severe financial problems with.
Inflation
Access to finance
Extremely large companies and finance,/institutions investing heavily in the armament and military industry.
As one sect