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success! , page-46

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    Congratulations and thanks to the scientific team at POH who put their heads down and got on with the job. An excellent, richly-deserved and vindicating result! Who would have thought...TPM isn't fairies at the bottom of the garden, it isn't a figment of the previous CEO's imagination, it isn't just a pipedream promoted by some deluded "true believers"...it's a drug delivery system with huge advantages and like no other in the world which has been PROVEN TO WORK.

    Many biotech investors understandably prefer to reduce risk by waiting until at least successful completion of Phase 2. While Phase 1 checks the safety and tolerability of a new drug product and works with healthy patients, Phase 2 is usually all about efficacy – does this drug actually work as intended on sick people? Obviously, that's key and when a drug development program fails, it’s usually at this point. So the stakes are very high at Phase 2.

    Here’s the reason for excitement

    Previously it was envisaged that the Phase 2 trial would need to prove that the product was capable of providing analgesia for patients with chronic pain conditions. As the Phase 1 result emphatically answers that question, the focus of the upcoming Phase 2 will now shift to defining the dosage regimes to be used with the product and enhancing its commercial value, rather than demonstrating therapeutic effect


    How good is that for a low risk Phase 2?

 
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