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Biotech / Medical : Paion
PA8.F 0.02200.0%Oct 8 5:00 PM EST
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To: NeuroInvestment who wrote (2)11/1/2006 6:41:20 PM
From: dr.praveen   of 10
 
Thanks Harry...My head is a little muddled now and excuse me for any mistakes.

Things I don't like about Paion: I think the 90Mug dose is a waste of time:-) Second I wish they had enrolled much more pts in 125Mug dose.Third I wish they could have also added a little higher dose like 150Mug seeing their dose dependant efficacy with the 90 & 125 dose.

For the things I like about them at the 125Mug dose:

Found DSMA is slightly more efficacious than Alteplase(10% improvement), more safer with lesser significant intracerebral h'age (1.7% and the tolerable limit is in excess of 9% by the FDA)and best of all the window period is elongated to 9hrs.

I found less than 7% of ischaemic stroke pts recieve Alteplase in less than 3hrs. Coz of this reason Alteplase was doing 300M$ in 2005. So Desmoteplase might cross the 1B$ sales barrier with the 9hr window.

Paion didn't disclose the royalty rates with FRX for US and Canada but Paion has copromotion option with Lundbeck for ROW.

Regarding safety, we already know 2 trials showed very good safety results at the current dose and the early 3rd trial results(1month) also didn't show any bleeding issues. 1 month is a good enuf time to know if there were any bleeding issues. It might be something to do with an doubtful MRI, MI or PE unrelated to the bleeding or simply to check all the pts MRI's? So I am reasonably comfortable with the safety aspect.

U can see the dose dependant efficacy with the 2 doses conducted.

So all in all an interesting Bio and I think the chances are better for this one unless something unexpected happens.

Cheers,
Praveen
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