ATH 25.0% 0.5¢ alterity therapeutics limited

What I want to hear most at the AGM…

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    …Is an update on Europe. There is something not right with FDA. It could be the off-label fight they are currently involved with. PBT2 is also being actively evaluated for Alzheimer’s (a non-orphan indication) and they may be concerned about giving accelerated approval to a drug that has a clear potential for off-label use (not as likely). Or, they have some other reason for delaying two HD orphan drugs and not being forthright with the HD community. Don’t believe for a minute FDA did that patient meeting on their own – they were made to. And this is what Bastings told HD sufferers… “I think that this is a good time to assure you that safety is not really what is keeping drugs from coming to the market. Again, we really recognize the severity of the condition and we take that fully into consideration as we [inaudible] assess? the risks and benefits of the treatment. And for diseases like Huntington’s we really [inaudible] safety issues before considering not putting the drug on the market.” Clearly not true. Perhaps there is some connection to another drug company that either has a drug for HD coming in their pipeline or there is a drug company that wants to keep Prana down. At the very least, Prana should have been afforded some sort of priority designation by FDA.

    Whatever the reason, the focus of PBT2 development should shift to Europe. Continue to check the boxes in the US but take the lead of Isis/Roche and go to Europe spending most of the effort to get a trial going under EMA. Tetrabenzidine was approved in Europe some 30 years before the FDA approved it. Roche took their AD drug to Europe for trials for gantenerumab and brought it back here when FDA got on board. Prana applied for orphan designation in Europe and this may be the fastest path to approval for PBT2. And what about off-label use in Europe- the Europeans are much more open to off-label and support it. Remember, the Europeans had very good things to say about PBT2 in their approval for orphan designation. "In addition, although satisfactory methods of treatment of the condition have been authorised in the European Union, the sponsor has provided sufficient justification for the assumption that the medicinal product containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride may be of significant benefit to those affected by the condition. The sponsor has provided preliminary clinical data that demonstrate an improvement in a relevant parameter when the product is used in combination with tetrabenazine. The Committee considered that this could constitute a clinically relevant advantage."
 
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