Classics, I think the news MAY be better. I could be wrong, here is my proposal:
PR Language - Clue 1: "Vivos Inc....has submitted the IDE Investigational Device Exemption...as part of a pre-submission meeting process."
---Quote from Blueprint document Step 3, "In summary, this is the time where you address any issues with the test plan and investigation plan, but is before the IDE is submitted".
Note that Dr.K did NOT say he SUBMITTED any test plan, investigation plan, or sterilization validations, biocompatibility testing, animal
study protocols, and/or clinical study protocols, pre-submission package, etc. Which are all part of Step 3.
Instead he says SUBMITTED THE IDE Investigational Device Exemption and he explicitly spells out exactly what IDE means: Investigational Device Exemption.
Step 4 is the IDE Submission
Step 4 says quote "Once the interactive pre-submission is complete and your data package is complete, it is time to assemble your IDE....Once submitted, the IDE goes through a 30-day review cycle. Since the 30-day review period is highly interactive..."
This appears to be where the process is.
TO ADDRESS YOUR TWO REBUTTALS (expected??):
1) But PR says "as part of a pre-submission meeting process".
As described either the first part of the statement below is wrong or the second part is wrong:
"has submitted the IDE Investigational Device Exemption...as part of a pre-submission meeting process"
Is the second part just being technically imprecise?
OR
Did the first part really mean test plan, or investigation plan or pre-submission package---when he said "IDE Investigational Device Exemption"?
Again he did not mention any type of submission but IDE, and then explicitly defined IDE. This is being very precise in defining what was submitted.
So I lean towards, he was just being imprecise when saying "as part of a pre-submission meeting process". I think he was VERY precise in his use of IDE Investigational Device Exemption.
2) PR Language - Clue 2: This review typically takes several iterations and we will continue with biocompatibility testing in parallel.
---I suspect, they got all the ducks in a row, except biocompatibility testing, and in their discussions with FDA, FDA said something to the effect, go ahead and submit the IDE, and while we review it, finish the work on biocompatibility testing.
One final bit of logic. What is the purpose of this PR?
Is it to say that we are in the middle of an iterative FDA process, or maybe to define a specific goal that was achieved?
Lets look at the first words of the PR. Good documents always define the purpose first, whether it is a story or a paragraph.
The PR starts with:
Vivos Inc. is pleased to announce that it has submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study
So, if we are in Step4, we should have IDE acceptance/denial within 30 days.
