A general marker for success rates through clinical trials -
60% of Phase I drugs advanced to Phase II
30% of Phase II drugs advance to Phase III
85% of drugs that are successful in Phase III trials then go on to gain approval and move to market.
Still along way to go but PAT-SM6 has a few significant advantages to ease it's way through clinical trials thereby further mitigating that risk.
Firstly targeting a rare disease shrinks that pool right down with limited options for patients & a big incentive for authorities to meet this need.
Secondly while the other competing drugs all have high toxicity these early stage trials have given SM6 a clean slate with a very safe profile & no adverse effects.
Thirdly FDA/EMA granting Orphan Status SIGNIFCANTLY increases the chanced of gaining final approval against other drugs outside of this designation.
Certainly still plenty of risk as there always is with clinical trials but Patrys have also had the opportunity to significantly mitigate it.
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