PBT 2.50% 3.9¢ prana biotechnology limited

Originally posted by m123456It's been even more frustrating to...

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    Considering the phase1 trial is due to report results 1H 2019 (as per 2018 investor presentation) it should not be possible to force another ADR reverse split by forcing the ADR price below $1 again. Even if the ADR does drop below $1 as we have seen it takes about a year for that to happen. For me, this short term ridiculously low price is not so important, so long as Prana can deliver on the P1 data reporting date, within the next 6 months, as indicated, and hopefully quickly as possible execute the P2. 

    As the AGM presentation reported

    • Several single dose cohorts completed

    • Multiple dose cohorts have been dosed

    Single ascending dose  (SAD) phase range between 50-1600 mg total daily dose, given as a single dose. The doses in the SAD phase are : 50 mg, 100 mg, 300 mg, 900mg, 1200 mg and 1600mg. It would have been nice to know which doses are complete.

    The multiple ascending doses are: Total Daily Doses (TDD) in the MAD phase are 200mg, 400 mg and 800mg, given twice daily for Days 1-7, and once daily on Day 8. 

    "The proposed doses will be confirmed based on the safety and PK data generated from the SAD portion of the study." According to the proposed trial plan posted at ANZCTR there was to be 8 weeks between the SAD and MAD phases, so this apparent overlap of the two studies may be a sign Prana does see the urgency of getting the results out ASAP, but I don't know. "The single ascending dose (SAD) and the multiple ascending dose (MAD) parts of the study will be conducted in sequential stages", so probably there has been 8 weeks between the lower dose levels of each phase.

    It will be interesting to see if Prana take the MAD 2 x 800 per day dose higher or lower as a result of the single dose 1600 cohort. The MAD study does contain a cohort of 10 elderly volunteers. A move on iron levels there, i.e. evidence of target engagement, could get exciting.


    All IMHO.

    Last edited by skint: 07/12/18
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