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31.0¢ paradigm biopharmaceuticals limited..

Please can you explain how TGA provisional approval is dependent...

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Gan_Gans

2,124 Posts.

568

14/05/23

18:47

Post #: 67766117
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Originally posted by ceviche: ↑

Just wanting to level set expectations.
My understanding

TGA is not off the cards for an application, rather it is dependent on the EU accepting that there is evidence of pain relief. That is one dependency.
FDA haven't been specifically asked yet if PAR need to include DMOAD in the upcoming trial that would otherwise satisfy pain relief. If the FDA doesn't, then the FDA might approve a fast path to a pain relief label independent of a DMOAD label. If they do, then any separate pain relief label is pushed out perhaps to the point it isn't sought, which reflects on EU progress and so a TGA approach.

So it would be a good idea for PAR to clarify
1. Will they ask FDA if there is a separate fast path for pain relief and for DMOAD labelling?
2. Either way, how would the FDA like that to happen
3. When are they (PAR) going to clarify that for us

I asked.

Clarifying those questions will go a long way to underpinning the share price.
The market places a step jump value on first revenue, otherwise you have a unicorn.
I am very much in favour of getting some revenue asap without detracting from a lot later.

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Please can you explain how TGA provisional approval is dependent on what the EMA says. This is entirely lost on me.

PAR Price at posting: $1.03 Sentiment: Buy Disclosure: Held
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