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re: when is fda approval for phase 1 human trials How long is a piece of string?
Yes, SBP have had their application in with FDA for several months. The delay is because the approval is subject to receipt of the results of animal trials in Canada which the FDA required; in addition to the Oz trials. These trials are purely for toxology purposes i.e. to establish/confirm safe levels for human patients. This had already been done in Oz(SAPS: special access patients=those with less than 4 weeks to live in the opinion of 2 specialists) have ben successfully treated over 18 months ago! Those that stayed after the formal business at the AGM would have seen some of the results on the slide presentation. I've seen a hellofalot more slides/photographs, but some people may have thrown up had they viewed them.
The Canadian trials are completed and Steve Carter is spending quite a lot of time in the states to be on hand to walk this appliation through. The FDA is totally happy with the application for ODS (orphan drug status) and Steve has formed strong links with the key personnel. The fact that SBP is after ODS (no cure yet for mesothelioma) may mean the final approval process is far more stringent.
Remember, there are many so called miracle cancer cures being touted around, that logic would say that the FDA would go over all of them with a fine tooth comb. In SBP's case, they have and all is on track for approval...........again-"how long is a piece of string".
I remain totally behind SBP.
For the knockers of SBP on this site; why even bother criticising posts (or SBP) when there are other stocks out there to invest in; or do YOU have a hidden agenda?
The rumour going around Perth last week was that final FDA approval was imminent. I have no knowledge to substantiate this!