Replies to post #21594 on Grapefruit USA Inc (GPFT)

[dan1drew2]

Benny - tx. yada yada as always.... Keep it comm'n


JB

[tattooed]

Nice post benny

[KingKong_Guru]

Benny..

Great DD as always ...
...

Approval is near ...read on..

1) DVIS is a perfect example of HW/SW co-design. FDA has to determine SE for DVIS Hardware and S/W.

2) Is hardware SE : Hardware is SE without any doubt , there are multiple predicate device with similar H/W ..O-Arm , fluoroscopy .., flat X-ray screen etc.

3) Is intended use SE: Yes DVIS will be used for existing procedure performed by other predicate devices.

4) Is S/W SE : Hmmm this is the million $ question. Certainly FDA is not interested in S/W algorithm used , SW package/language , S/W complexity On2 or nLOGn ..which DSP process , etc ..Only thing matters for FDA is the final outcome of 3d S/W ..i.e Image quality to perform claimed procedure.

In the last submission FDA was not able to determine whether images are substantially equivalent to images from predicate device ..because DVIS generate images in real time 3d.

The best way for FDA to determine image equivalence is to get opinion from radiologist ..Same thing happened to Meditronic O arm also.

Now If radiologist rubber stamped (which I strongly believe) image equivalence ..then FDA finds DVIS 3d S/W SE.

DVIS HW (SE) + DVIS SW (SE) = DVIS (SE)


IS_guru

[BennyJ]

IMGG 510k is in interactive process. - Reposting
Whoever has already read this post, ignore this and move on.

- FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.
- Since April 5th submission lot of communications between FDA and IMGG. FDA never put a hold on review clock since April 5th. All are informal request/response. No AI formal letter.
- Read the interactive section in the below link to learn more.
- Based on my research, Final decision after the final response varies between 15 days to 45 days(after july 5th response). So approval could come any day in following days.
- All the things are aligning now towards the approval news.
- Buy and Hold or accumulate/average down and be in stock.
- Don't listen to basher or even to me except your own DD/research.
- Whoever is doing bashing now, either they do flipping on their tradeable shares or shorting. But still maintaining their core positions.
- Play safely. Whoever is down 50% and above, after the approval news the stock price will skyrocket.
- People say, there will be sell off due to PPM shares after the approval, no it is not. Lot of PPM share holders know that this company will be sold out for huge premium between 6 to 8 $, they are not selling. The stock price went down due to orchestrated bear raid by some well known sites. They do this constantly to buy cheapies from panic sellers.
- FDA is in final stage of the review process(performance data review/radiologist review comparison)
- Mark this post. Approval is before September 5th(150 days for 98%). Could be any day. Remember, FDA will not sit and wait till september 5th once review is done. They will fax it and news will be released during trading hours(I wish).

I. REVIEW PERFORMANCE GOALS--FISCAL YEAR 2008 THROUGH 2012 AS
APPLIED TO RECEIPT COHORTS

All references to "days" mean "FDA days."

A. ORIGINAL PREMARKET APPROVAL (PMA), PANEL-TRACK PMA
SUPPLEMENT, AND PREMARKET REPORT SUBMISSIONS
FDA will issue a decision for 60% of non-expedited filed submissions within 180 days, and for 90% within 295 days.

B. EXPEDITED ORIGINAL PMA AND PANEL-TRACK PMA SUPPLEMENT
SUBMISSIONS
FDA will issue a decision for 50% of expedited filed submissions within 180 days, and for 90% within 280 days.

C. PMA MODULES
FDA will take action on 75% of PMA modules within 90 days, and on 90% within 120 days.

D. 180-DAY PMA SUPPLEMENTS
FDA will issue a decision for 85% of 180-day PMA supplements within 180 days, and for 95% within 210 days.

E. REAL-TIME PMA SUPPLEMENTS
FDA will issue a decision for 80% of real-time PMA supplements within 60 days,and for 90% within 90 days.

F. 510(K) SUBMISSIONS
FDA will issue a decision for 90% of 510(k)s within 90 days, and for 98% within 150 days.

Read Section H. INTERACTIVE REVIEW in the document, link has provided below, Above information also has been taken from the same document

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA