Yes, unfortunately, controlled studies is what has been required for many years now. I spoke with company more than 3 years ago about this and it is because the company was for years denying that I sold my holding.
There is a bright side - based on the preliminary pilot data we all believe that the product has potentialility for good clinical outcomes. With data of controlled studies we will know - not wish - that it is effective or not. If demonstrated effective it will become available, will be purchased and used by clinicins and will be benefit to patients. If not effective, well, a potentially promising approach was finally tested, we learn from errors and improve.
To other comment, there must be 2 separate trials. A phase 2 trial, controlled design of small number patients will be suitable for CE, then a larger controlled Phase 3 trial for FDA. Sorry, but there is no avoiding. The company would be making a very big risk if they started now a definitive FDA Phase 3 study without doing a smaller Phase 2. This would be very unwise. If properly designed and funded P2 study could be completed in 12 mo and if data strongly supportive a P3 study could be completed in 24 mo. Wishing and hoping is not an effective strategie.
As a point of note, Dr Harding of Cardiff has been working with another Australian company getting controlled studies underway since 2013.
TIS Price at posting:
10.5¢ Sentiment: None Disclosure: Not Held
