GREY:TSTIF - Post by User
Comment by
BernardBaruch60on Nov 26, 2018 1:59pm
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Post# 29022508
RE:RE:RE:RE:RE:Liability
RE:RE:RE:RE:RE:LiabilityThank you for the reply Echo, I appreciate your thoughts as I am in still in a research phase. I do not understand why the FDA and CDC have only used EtO to sterilize scopes from an outbreak, even after VP4 has received its clearance. Even if they offer other methods to sterilize, they have only used EtO to stop outbreaks, so when it's time to manage an outbreak, they're using an EtO sterilization method and not ours. Is there a compatibility issue with certain complex scopes and H2O2? Do we know if individual EtO sterilizer companies have validation and waiting on clearance from FDA? I see we even have a compatibility disclaimer on the bottom of marketing material referencing this risk. Also, I found 2 EtO sterilizers with 3-hour sterilization times, but 12 hour aeration times. So, not 24-48 hours as previously stated, but I still don't understand with the difference in sterilization times how VP4 doesn't win everytime? What role does the biological indicator times have in releasing instruments? I know 3M has a rapid readout at 1-hour vs our 18 hour BI time. So, in theory, if standard of care is to wait for the BI at a hospital, the total time for VP4 would be 18.40-19.10 hours verse 16 hours. But, if sterilization is not mandated at the moment, then would the BI times even matter? What would a hospital do if they used a reprocessed scope on a patient only to find out 12 hours after surgery the scope had a failed biological indicator? These are questions I have not seen on this board. I already have a position on this company and looking to go bigger, but I have questions, beyond company leadership, and more towards the environment we are selling into as being the culprit for lower than expected sales. Interested in hearing feedback from veterans of this stock, such as yourself.