LTP is targeting an NDA with the FDA early next year - that is an application seeking approval to sell Spontan. Usually takes FDA about 9 months to approve or reject but LTP will seek to expedite to 6 months. LTP is looking to have a meeting with the FDA in the balance of this year to plan for the above. Generally speaking, biotechs at that stage have a market cap in the multiple 100s of millions. There is also an application to be filed with the TGA for Australia around mid next year and then other jurisdictions. Of course, the company has already started selling in Australia under SAS with strong demand from prescribers and patients - expect this will continue to grow.
ED Game Changer, page-10
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