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Re: None

Thursday, 10/13/2022 2:16:52 PM

Thursday, October 13, 2022 2:16:52 PM

Post# of 459912
Partnership NOT the reason for NO TLD/CTAD PRs!!
Reasons:
1) Negotiating strategy. One does not negotiate early from a position of weakness. That is no data in hand, or no imminent approval. The converse is then true, one wants to negotiate when sales/approval are imminent. Approval/sales is down the road a while, not now.
2) Announcing a partnership with nothing to sell would be silly. At this point Dr.M should be holding DISCUSSIONS with VARIOUS POSSIBLE partners (distributions/manufacturing). He is not discussing TERMS yet, just assessing, and narrowing the candidates.
3) You do not want to announce a partner before discussions with FDA, as that would be seen as putting pressure on them to approve drug. The protocol is never to be seen making assumptions of what the FDA will do!! The earliest I would expect to see partners ANNOUNCED, would be after significant discussion with FDA, maybe only after approval, or imminent approval.

Dr.M is a known good negotiator, with years of pharma experience. So you can assume he knows all this. Trust him on this.
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