Some pretty impt notes. Obviously the ANP management has given the feedback to Wilsons and Morgans..
Whilst this is a small set-back, the key point remains that FDA is at the table and open to the idea of approving ATL1102 on the basis of a single Phase IIb/III trial.
ANP are still on track for a CY21 start for their pivotal EU Phase IIb study. We expect to hear regarding final PIP approval toward end of 3Q’CY21 with all EU preparatory trial plans rolling full steam ahead.
This is the key catalyst for the market in the near term. EU prospects are the primary driver of our valuation.
FTD refusal here is not based on any clinical evidence review – it is administrative.
Not only is ANP primed for a registration trial in Europe which would set it up for first potential marketing approvals, it is also a larger market opportunity (TAM $1.7B vs $0.9B) with less competitors (i.e. no exon-skipping), a larger addressable DMD cohort (2-3x), and a market where ANP have strong relationships with trial clinicians that are highly beneficial to eventual market entry and clinical adoption. These are still being built in the US market.
Looks good medium term..
IMO
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