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I want to dump the CEO for:
1: The UK coverage debacle
2: FDA clearance for knee almost 2 years-no attempt to gain sales
3: FDA clearance for foot almost 2 years-no attempt to gain sales
4: Not having FDA specialists submit the Musculoskeletal 510k
5: Having Dr. Scholls phyicslly in the building for (2years?)and no deal as the patent life dwindles.
Those are a few reasons off the top of my head.
Innovation challenge- No go
https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm
Next up 510k for recovery rx
FDA innovation challenge https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm
List of Applicants Selected for the Challenge
The FDA received an overwhelming response to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. Over 250 applications were received from medical device developers large and small. After careful review using an established set of criteria, eight challenge participants have been selected. The medical devices from the selected participants include those intended to predict the risk of opioid used disorder (OUD), detect opioid overdose, dispense medication and provide pain treatment alternatives to opioids.
Company
Product Name
Category
Algomet Rx, Inc.
Rapid Drug Screen
Monitoring
Avanos
Withheld Per Company Request
Other
Brainsway, Ltd
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) Device
Opioid Use Disorder Therapy
CognifiSense, Inc.
Virtual Reality Neuropsychological Therapy (VRNT)
Pain Therapy
iPill Dispenser
iPill Dispenser
Medication Dispensing
Masimo Corporation
Withheld Per Company Request
Overdose Therapy
Milliman
Opioid Prediction Service
Diagnostic
ThermoTek, Inc.
NanoThermTM and VascuThermTM Systems
Pain Therapy
Buy and hold in pennies is a losing strategy 99 percent of the time. It works in dividend paying stocks pretty well though. I had a large amount of dry powder recently, I had some temptation to go all in on BIEL, that was .0022-.0023 range, thank god my cravings for dividends won out. Truly only invest what you can afford to lose in pennyland.