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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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From: Lance Bredvold3/28/2023 11:28:45 AM
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"..."We are delighted with our progress towards achieving a PMA for the SurVeil DCB," said Gary Maharaj, Chief Executive Officer of Surmodics, Inc. "The feedback from the FDA provides the necessary clarity on the process and content required to successfully amend our PMA application. Importantly, we do not anticipate the need for additional biocompatibility studies, which will significantly reduce our initial assumptions of the time and cost to amend our PMA application. With this alignment and clarity, we are preparing our amended PMA application for submission in the third quarter of our fiscal 2023 with a target of receiving premarket approval in the fourth quarter of our fiscal 2023."


Letter from FDA announced today is about what I hoped and expected. Now a bump in the road to probable acceptance and the stock has bounced 10% so far. The company took dramatic action for a worst case scenario by reducing the sales team it had built and cutting back on expenses just in case. I would think the consolidation of sales territories might actually be beneficial as those which are less promising or people who are less enthusiastic might be culled. Thus, while I'm not convinced all is rosy, it sure looks pretty good and I bought (too much) at $25 and then just a bit more at $19.70. Clearly wish I'd waited for $16 but the budget was spent by then. I still expect to make money in the next year or so as we watch the rollout of SurVeil--maybe. I have faith that SRDX scientists know what they are doing as they've been helping others with coatings and balloons for so many years.
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