For what it's worth, I think the hold up on the deal is more related to the dosage response that we're waiting on from the FDA than anything else. knowing how the FDA likes to add new requirements in their responses, I'm guessing the new partner wants to see their response before they ink the deal, especially if they're including a small upfront payment under the assumption the BLA will be submitted following the FDA's response.
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My comments are just my opinions and should NOT be taken as investment advice.