1) I am told that the decrease in dosage was not due to any incipient adverse effects, which would have been the negative possibility> Gad Reisenfeld is not back in the US until next week, so my speculation regarding pharmacokinetic hypotheses is simply that; perhaps they are finding that there is a ceiling on how much HU211 actually is absorbed into the CNS, making a doubling of the dose superfluous. In that case, 200mg may be an attempt to make a finetuned differentiation of optimal dosing (whereas 150 vs 300 would have left too much gap 'in between') for Phase III).
2) Increasing the number of sites could allow them to increase the sample size if they are not sure the trends are strong enough in the cohorts done so far, it also could allow them to complete the trial faster if they stayed with the same N, thus allowing a Phase III to start earlier.
3) By the way, since there has been some confusion about the $900,000: this is gross (@29%) revenue from B&L. PARS must now send back monies to B&L as loan repayment, pay royalties to the inventor, and pay for the product. My rough calculation is that they get to keep $540,000 or so for themselves (900,000-(900,000*9%)-(900,000-31%). NeuroInvestment (www.neuroinv.com) |
