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Ann: Update on Novartis Agreement, page-555

  1. 5,480 Posts.
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    last time a partner walked (Teva), they handed back the CHF program for free.. and apparantly that program was worthless. Stock went down to $1 I recall...

    That trial read out and now those trial results are being presented to the FDA for a potential accelerated approval.

    While my suspicion is that Novartis walked due to a bad OTAT outcome... I appear to have been wrong more times than right, so chances are... I'm wrong on that too

    CHF accelerated approval BLA still on the cards, so is Ryoncil BLA re-submission. CLBP has gone off radar, but don't think that was going to result in a BLA, rather best case is a confirmatory trial.. which will require a partner to fund.

    If Ryoncil is approved, being on our own is just fine.

    If the CHF accelerated approval BLA is given the green light, I don't think we'll be alone for long.

    And if we get the COVID ARDs trial BLA up and running, the NIH funding that trial would be a likely outcome.

    Goodluck all


 
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