Interesting comments from Morgans re tox studies end of CY21.
Is the Murdoch Institute study - was due November - needed before FDA tox submission?
Looks like it:
▪ FDA clinical and tox submission (late CY21), new indications (CY22), trial recruitment (CY22), trial commencement (CY22), futility analysis (CY23)
Note Morgans linking of the FDA tox study to possible M&A action.
However, looking forward we view ANP as a prime target for a number of players, particularly in gene-therapy where inflammation is believed to be a drug class effect which raises an immune response to the treatment.
When do we think this will happen? With cashed up competitors, anytime is possible although we think the key lies in firstly de-risking the US program (tox study)and outcomes of further studies investigating the combination with ATL1102 and dystrophin restoration drugs.
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▪ Our fair-value valuation increases to A$0.58 (from A$0.45).
▪ Our unrisked valuation rises to A$2.62 (from A$1.82).
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I still can't reconcile the timeline published with actual readiness...all very murky.
Looks like they're trying to coordinate one global study - slowing EMEA to let FDA catch up.
