STRONG SELL/ 50% downside potential, page-32

@RaceOncology - - I take your points and obviously my understanding in this area is nowhere near yours.

However, MSB were told that double blinded trials on children were not required/allowed and therefore did not complete a placebo trial. Low and behold it was given a CR. The reason - it did not undertake a placebo trial as the FDA did a huge about face at the last second. Even it’s application for accelerated approval for an unmet need which it qualifies for given no treatment exists for children looks like failing for the fact no placebo trial was run.

PAR has also intimated now that FDA wants more patients and 4 year trial, changed from a 2 year trial, thrown in at the very last minute to the shock of all. it had been advising the market for months that its trials will be 2 years.

as you can see from these two companies, the fda changes it’s mind all the time so unless the FDA has signed on a dotted line saying data will be accepted and there’s no going back I just want people to understand this is not set in stone. However, I do not know what FDA has said in this regard so cannot comment other than general warnings as set out above.

anyways rac and wombat I have enjoyed this discussion and please no one take this as downramping. Quite the contrary - I believe rac has huge potential and is a great investment. However, I have invested significantly in biotech companies in my time and unfortunately have yet to see massive gains due to the volatile and ever changing nature of FDA.