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Biotech / Medical : SRDX - SurModics - Biotech IPO
SRDX 31.15+5.7%Apr 28 3:59 PM EDT

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To: Lance Bredvold who wrote (61)1/19/2023 8:06:47 AM
From: Lance Bredvold  Read Replies (1) of 83
 
Well, that's a bummer. Premarket approval delayed by FDA request for more data and also a labelling requirement. Price is down 20% premarket offering $26 at the moment from over $37 yesterday at the close. Gary says an immediate reduction of spending will be called for and meeting with the committee. It must be serious and he says additional data will be required so certainly more time for SurVeil before sales could begin.

But again, I'm impressed that Gary bites the bullet at 0700ET and does not sugar coat a bad situation to improve my hopes. I have been disappointed that Value Line dropped regular coverage of SRDX last year and now this with the sales force costing a lot. I have no idea how long this delay will be--or if it might require a complete retreat to the old model and reduction in selling expense--I doubt that, but it's possible. Remember, SRDX was always profitable until last year when they made a conscious decision to sell stents independently. The progress payment almost certainly now maximizes at $27mm and, I think I recall that there are further reductions by Abbott if PMA is delayed still further.

Ouch.
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