FDA submissions under medical devices.
The path for reviewing and obtaining FDA approval is complex and extremely expensive.
While it is possible that the updated financials are to enable the needed funds to cover this cost, it is a bit earlier to draw this conclusion, given the present price point.
Assuming the application follows the format of “medical devices”, it is a faster and less expensive format. On average, a medical device application can take up to seven years compared to the drug approval process of 12-years. However, on the flip side, FDA has been working since 2014/2016 to improve and streamline the process of approval under Medical devices. This was actually sought by the agency in 2016 if memory serves me.
My assumption of a faster timeline is based on the approval process falling under a Class I, “low risk” review.
Medical devices follow a similar FDA approval process as name-brand drugs. Testing usually begins in a laboratory and progresses onto animal testing to address safety concerns. Then, the devices can be tested on humans to ensure safety and effectiveness.
An FDA decision can be made after the submitted data is reviewed. If approved, the device will be classified based on risk.
Class I devices are low-risk and non-surgically invasive devices such as bandages, handheld surgical instruments, and nonelectric wheelchairs.
Class II devices are moderate-to-high risk devices such as syringes, catheters, and contact lenses.
Class III devices are high-risk devices used for sustaining or supporting life or preventing impairment of human health such as pacemakers, fetal blood sampling monitors, and implants.
Like you, I'm not an expert when it comes to the FDA approval process. Especially, when it comes to odor control in senior diapers....LOL
All this being said, seeing revenue contracts and updated financials is a good thing for the longs here, while we await updates on the FDA approval process. At this point, my focus is on negotiations directly tied to product agreements, subject to the final FDA approval.
