The current timeline should remain unaffected, running in parallel with the ongoing FDA engagement, which was already confirmed. This offers an opportunity to gather additional scans and data concurrently, making efficient use of time. The progression to stage 3 won't extend the overall timeline, as it aligns with the ongoing FDA engagement, and the time required for this has already been factored into our forecasts.
Instead of letting this time go to waste, why not utilize it to conduct scans on additional patients, especially those with bleeding cases? The prioritization of determining "bleed or not" is crucial for clinicians, given that the standard of care involves using plain CT scans to assess this aspect. Interestingly, this aligns with one of the algorithms within the EMV image. In critical situations, ruling out a bleed is of utmost importance, in line with the established standard of care. Consequently, to position this as a marketable product, emphasizing the capability to rule out bleeding becomes essential.
Considering the expected time for the FDA engagement, why not seize this opportunity to gather more 'bleed or not' data in parallel, as mentioned in the announcement?
It's worth noting that plain CT scans are not particularly effective in detecting clots. Thus, being able to address this aspect, at the very least, makes a compelling case for the EMU's utility and potential for widespread adoption among industry groups.
Regarding the recent sell-off, it's important to mention that some individuals appeared to be selling hastily on Thursday afternoon as well. Therefore, it's unlikely that today's selling activity is directly tied to the news announced today. It's more likely that today's sellers had their own reasons for selling, unrelated to the recent announcement.
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