RE: Stu's ROLL OF HONOUR17 May 2023 14:34
I'd love to say "Good Try" Stu, but its actually really rather poor. It was not a LIE, it is my current belief on what i have read in HEMO RNSs and the FDA website.
RNS states (1) that directors have agreed they have cash for 12mths and (2) that it will allow them to progress into into clinical trials (PLURAL - not singular in your manipulative post)
As you can see, the FDA state that Phase 1 is a small phase and should take a number of months.
I'll make a note of your post and make sure it goes in the next update of your ROLL OF HONOUR
From 'Final Results' RNS:
On 26 January 2023 the Company raised gross placing proceeds of £4,056,250, which will be used to facilitate progression of the Company's HEMO-CAR-T product candidate into clinical trials and to enable the Company to continue development of product candidates for the treatment of viral infections based on its CBR platform.
Note the PLURAL "Trials"
and in same RNS
The Directors, having made due and careful enquiry, are of the opinion that the Group and Company have or will have access to sufficient funding in order to execute its operations over the next 12 months.
And from FDA Website:
Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
Phase 1
Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Approximately 70% of drugs move to the next phase
Note the typical time scale of Phase 1
Phase 2
Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase
Phase 3
Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Approximately 25-30% of drugs move to the next phase
Phase 4
Study Participants: Several thousand volunteers who have the disease/condition
Purpose: Safety and efficacy