PBT 4.26% 4.9¢ prana biotechnology limited

A sea of green except.....

  1. 476 Posts.
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    Yes a green watch list except for one stock.

    Its like they purposely chose Friday the 13th to announce this bad news, despite the day being very lucky for the majority of stocks.

    It highlights PBT inexperience with clinical trials and dealing with the FDA. I am sure if they were partnered with a big Pharma that all the i's would be dotted and the t's crossed. It seems quite incredulous that PBT would submit a higher dosage human trial for phase III without having any evidence either in animal models or early stage II human trials that such a dosage is not toxic.

    Whilst I am sure PBT is confident that a higher dose will be safe, it will set them back at least 6 to 12 months in obtaining the data unless they can provide the FDA with some existing safety data in the interim. The AD extension trial which I believe is due to report findings before end of March, continued to dose the patients using 250 mg. Lets hope that there is some good news from the extension trial as long-term share holders need some respite from the back to back bombshell announcements of the past year.

    Rudi Tanzi has developed a so called "Alzheimers in a dish", a cell culture model which is purports be able to perform drug trials in a petri dish taking a fraction of time to gain important information that would normally take years in clinical trials usually performed on animals. Don't think that the FDA would accept such data though.

    I guess you can say that it is a buying opportunity with the stock being at a 52 week low. Eventually PBT will supply the FDA with the data and hopefully they will get the nod for the phase III trial. It seems a bit odd though given the orphan status granted on PBT2 to potentially fast track the approval process that this decision will actually slow the process but in the end, the safety of patients is the FDA's main concern and priority.
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