Competitive/tech risks: PNV operates in a relatively crowded therapeutic areas, there are over 60 companies which sell graft products, and over 70 hernia repair products on the market. Both areas are very heavily supported by larger sales teams, and incumbent products exist in both marketplaces. There are a variety available products for treating physicians to choose from. Our forecasts rely on PNV’s devices and technology being superior in the long-term to alternative options, to drive clinical adoption and revenue growth. Clinical trial risk: PNV products are being evaluated in multiple clinical settings. The failure to show a clean signal in clinical trials can lead to years of delay, as those trials are redesigned (often explored in different patient groups, measuring different clinical endpoints) or simply repeated. Worse, clinical programs can be discontinued completely if the data does not warrant further advancement. Trials can fail on account of the product not being safe or effective enough or through poor trial design and execution. Wound care trials are notoriously difficult, since patients have a variety of underlying conditions which can confound the ultimate treatment outcome.
PNV pay for this coverage so holders need to either believe what they read above or H/C posters. Sales so far I would suggest the above is more the truth.IMO
Aloha.
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