Ceapro Inc V.CZO

RE:RE:Interesting Chart Pattern Shows.......

[Ciao]

Oats,

Your point # 4) Beta glucan pill trial was to commenced enrollment this month

I believe you mean complete enrollment as trials are already underway, they needed to complete enrollment to accomodate their request to modify the study to allow participants that only wanted to take the BG pill as a stand alone treatment

I'm somewhat excited by the talk of starting human clinical studies as if one looks at the phases and that we are dealing with Y-BG which is an approved pharmaceutical additive. Safety is not an issue.  The key would be setting the correct dosage and determining the effectiveness. I don't see any red flags moving into the various stages.  

I can see parallel studies for its use to treat fibrosis as a result of asthma or COPD, which broadens the scope of PGX Y-BG.

From Health Canada, stages of clinical trials

• Phase 1: These trials test an experimental drug on a small group of people for the first time. The purpose is to:
  • look at the drug's safety
  • find out the safe dosage range
  • see if there are any side effects
• Phase 2: The drug is given to a larger group of people (usually 100 or more) to:
  • gather data on how well the drug works to treat a disease or condition
  • check the drug's safety on a wider range of people
  • figure out the best dose
• Phase 3: The drug is given to even larger groups of people (usually 1,000 or more) to:
  • make sure it is still effective
  • monitor side effects
  • compare it to commonly used treatments
  • collect information about the drug that will allow it to be used safely on the market
• Phase 4: These trials take place after the drug is approved and is on the market. Information is gathered on things like the best way to use a drug and the long-term benefits and risks.