@stoic_point Great to see Evolv’s system in Warsaw one of the safest cities in Europe, where hardly anyone owns a gun and knife incidents are almost nonexistent.
Few casual thoughts on the Google trial + a side note on $PUBM.
If you see it differently, drop a comment -always curious to hear other takes.
https://t.co/0gfIlhjTBN
$TMDX We have submitted a Citizen Petition with the FDA requesting suspension of Pre-Market Approval (PMA) for TransMedics OCS devices, particularly OCS Liver, which is the bulk of its usage. Link at bottom. We believe that:
1) The vast majority of OCS Liver usage is off-label, inconsistent with and contraindicated by the label, as well as inconsistent with the pivotal trial which was the basis for FDA Pre-Market Approval;
2) OCS Liver is prone to safety issues and malfunctions resulting in necrotic livers, which we believe results in injured/damaged livers being transplanted into patients and resulting in poor transplant outcomes. We believe these safety issues, predictably, are the result of and/or exacerbated by the off-label usage;
3) The off-label use is promoted directly by TransMedics; and,
4) TransMedics is engaging in alarming business practices which suggest to us an attempt to conceal safety issues from hospitals and the FDA
https://t.co/jCNv890usk
@ParisAnalyst shared a lot of interesting insights about the competition of $evlv in his post https://t.co/DmEGs4Nlpj — highly recommended for those who are curious about the company's competitors.
@ParisAnalyst shared a lot of interesting insights about the competition of $evlv in his post https://t.co/DmEGs4Nlpj — highly recommended for those who are curious about the company's competitors.
@ParisAnalyst shared a lot of interesting insights about the competition of $evlv in his post https://t.co/DmEGs4Nlpj — highly recommended for those who are curious about the company's competitors.