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Optimus78

116 Posts.

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12/08/24

17:55

Post #: 75173598
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Originally posted by strangelogic: ↑

In the video around 42 min mark PR is responding re the TGA provisional approval.

PR also noted that most provisional approvals have been in the cancer treatment space and PAR would have to convince the TGA of the urgency of treatment for OA.
This is a risk in my mind as new cancer treatments that would be provisionally approved are commonly addressing obviously life-threatening illness. OA may not be deemed as urgent in context. However OA is a big problem with significant comorbid diseases so that may have some influence. (Anxiety, Depression, Fibromyalgia, Diabetes mellitis, Hypertension, chronic Kidney disease, NSAID complications, and obesity)

He noted a minimum approval time of 12 months from full dossier submission. PR put the guess of July/August 2025 which tells me he has an expectation of a response to the preliminary request to submit in the next 3-4 weeks with a quick turnaround on full dossier preparation and submission.

If approval is gained then they will need to organize a local distribution agreement and supply logistics. I would say that is a 2-4 month exercise if one includes ramping API procurement and formulation.

So Revenue from TGA provisional approved sales would not register on the P&L until 2026 IMO.

To me, the company's survival is all hinging on phase 3 go ahead with significant deals in the order of 100 million USD (80 for trials and 20 to run operation).

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no I quoted from the 40m27s mark and it's only fda when he says that line leading up to it, can Somone please confirm as I just watched it again.

PAR Price at posting: 23.0¢ Sentiment: Hold Disclosure: Held
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