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No, rational people won't. The things posted on this board become public, so you should like them. What is more credible, a random post on a pump blog or posts that relay info from company representatives and have years long posting histories on this board.
If you take a deep breath and think about it, I am sure they will agree with me on the subject. :)
I don't think they have the resources or manpower to have two active submissions at the same time, not to mention the people involved in grilling hotdogs on fridays.
From paul
We are planning to submit both the 510(k) for post operative pain and an application to participate in the FDA's Innovation Challenge. The participation in the Innovation Challenge presents the opportunity to get an indication of use to mitigate opioid use.
So I wouldn't call it bait and switch, either way we need full clearance AND Dr Scholls agreement to have any sustained price rise.
If they are accepted into the challenge they will need to do a 510K. No bait and switch.
FDA review divisions and management will work closely with developers of devices accepted into the Challenge. In most cases, applicants will eventually submit one or more formal applications to the FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.
ActiPatch fits well into the challenge
Criteria for Challenge Application Review
The Challenge was intended for diagnostic or therapeutic medical devices, including mobile medical apps, that address the opioid epidemic by preventing and treating opioid use disorder (opioid addiction). Potential examples of medical devices that may address this problem include, but are not limited to, diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or -replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.
Well, there is much to be cynical about. If I didn't personally have repeated great results with Actipatch i would have bailed ages ago.
As far as the FDA goes, BIEL has no control over that, so we wait. The CVS soft rollout was unexpected and positive. B Braun choosing to use ActiPatch in it's joint replacement kits will hopefully start showing up as sales soon, so take heart, maybe we can overcome amateurish management.
Forgot 1 other major positve, Steve slapp'n the ask baby
I think a good bit of that fall was from Not marketing your 2 US cleared products, either of which could make a small Co profitable. Before saying they have no $ for marketing, that is what a 5B share increase should be spent on. All the while Bayer eats free hotdogs every Friday at BIEL HQ, maybe they'll hang out for 10 more years till the patents expire and then pull out. :)