12 months ago they were planning to submit a NDA to the FDA at the start of this year and TGA mid this year as per this presentation.
https://hotcopper.com.au/threads/ann-investor-presentation.7906290/
now, a NDA I’m expecting to be late 2026. So in 1 year, they’ve experienced a 18 month delay….
misleading shareholders, complete incompetence of clinical and regulatory process, terrible communication - pick your poison.
i think they knew this was coming and I assume, were advised by consultants of expectant delays hence the significant raise which, at face value for information on hand at the time - had no purpose. obviously, it had a purpose. Hold them over without needing to do a big cap raise with massive dilution.
I’m not surprised though no timelines are given around the next trials - they would’ve just found out what had to happen from the FDA. I’m expecting absolute best case, these trials start this year. May take 1 quarter from initiating, recruitment, dosing, results and analysis - that’s probably end of Q2 2026. Then, IND somewhere and then prepare an NDA - 3-6 months, to get an application in for approval, I can’t see FDA approval before 2027 honestly.
I sold a bunch when major support was broken, timing is everything in biotech and I see it going lower in the short to mid term because now, complete loss of investor confidence based on the dreadful communication.
for me, it’s going to be hard to buy again, especially if they get this new product marketed first. I see it will potentially erode their future market opportunity with Spontan. I.e. why would someone swap over the Spontan for a premium price if it does the same thing as this new product? Could doctors advise - they can prescribe spontan, or patients can try another product that can be compounded which is significantly cheaper…
mulling this over more it’s a crazy position. truly rooted shareholder confidence
(20min delay)