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Your analysis is totally contrary to the facts. The reality is, the longer it takes, the less likely it is to be bad news. Look at the data that Guru has posted, or look at the FDA's website if you have reason to doubt the accuracy of his numbers. NSE determinations are made quickly, SE, particularly in hot button industries like radiation emitting devices, takes time.
Remember this, just because something takes longer than you would like it to take, doesn't mean it's delayed. You ask why the delay in SE, and I say, what delay? I wish we would have heard by now, but what delay are you talking about? The FDA has not come back and asked more questions, which would be a delay, they have not sent a "Hold" letter, which would be a delay, and they have not come back with an Additional Information action request, which would be a delay. So I ask, what delay are you talking about? We are 3 weeks short of the longest time the new FDA has taken, which was over 180 days, at the end of which was a determination of SE for a radiation emitting device. In the mean time, we have received no bad news from the agency. To the contrary, we have been told twice now that they did not have any additional requests or questions. We see on their process review flow chart that we are at the final box, and that what the FDA expect to satisfy that final box is a review from a radiologist in exactly the same form as Dean sent them.
I wish we would have already heard by now, too, but that doesn't mean there is a delay and it absolutely doesn't mean a "bad indicator," since every single one of the NSE's reported by the FDA since the new FDA team has taken over, have come within 60 days of the submission and did not involve back and forth exchanges b/n the review team and the applicant. We'll hear when we hear, and I'm betting big on SE, especially based on the way this review cycle is playing out.
I did not understand that to be in a separate communication from one of the Radiologists, but rather, was included in the Radiologists' report. Dean said it publicly, it was not a message board rumor.
Thankfully, we don't need to guess about this anymore, because we already know for a fact that 2 independent, expert radiologists reviewed images from the DViS in all its modalities and compared the diagnostic value of those images to that of the competition, and concluded in a document in which they stamped their credentials and submitted to the federal government that the DViS was at least as good and likely superior. Then they ran out and bought stock on Imaging3.
You really shouldn't put things inside quotation marks that are not direct quotes, or for that matter, even reflective of what he said. Dean did NOT say: "Problem with comparing our device because nothing exist like it." Nice try slipping that in there, but that's not true, that's not what he said.
Are you suggesting that FDA delays in the 510(k) process have affected many applicants other than Imaging3? The way some people around here post, you'd think that Imaging3 was an outlier. I guess this goes to show that that's nonsense.
Of course I disagree with that, it's plain wrong. You say the first team "ended up with no SE determination." That's not true, or at least is misleading. The first team didn't "end up" at all. They didn't finish the process before they were all kicked to the curb for being terrible at their jobs. To the contrary, all indications were that they were about to issue an SE letter when they were fired, so I don't agree with that part of the statement at all.
I also don't agree with the part of the statement where you say "the second team is beyond statistical deadlines." How many times have I and others repeated THERE ARE NO DEADLINES!!!!!! The FDA has absolutely has no deadlines for responding to 510(k) applications. They have goals. Sometimes they meet their goals, sometimes they don't. They have, most recently, run past those goals for other radiation emitting devices, but did eventually (183 days was the longest) get the applicant an answer... SE in 97% of the applications, actually.
I can understand frustration with the wait as well as anybody, but to suggest it's never going to happen is just foolhardy. Patience is critical when dealing with a federal bureaucracy, especially one that does not have any deadlines.
Yeah, that makes a lot of sense. The road is littered with all those companies that never got a response from the FDA ever. That has never happened and it will never happen. It may take entirely too long, but applicants always get a response. Frankly, the quickest responses are NSE responses. The FDA can tell pretty quickly when they can't find a legit comparison with a predicate and get that response out quickly. It takes a long time to work all the way through their review process flow chart to get down to SE, but that's where we are.
Do you deny that the FDA has published its 510(k) review process flow chart?
Do you deny that the flow chart reflects a start to finish chronological order of the FDA's review of 510(k) applications?
Do you deny that the last box before SE in the 510(k) process flow chart is a request for and review of "Performance Data"?
Do you deny that we have seen at least one recent example of the FDA describing "Performance Data" to include a review by a radiologist of images from the application device and a predicate device for equivalent diagnostic capability?
Do you deny that the FDA requested from Imaging3 a review by a radiologist of images from the DViS and its predicates for equivalent diagnostic capability?
Do you deny that Imaging3 supplied to the FDA a review by not one, but two, third party radiologists who concluded that the images from the DViS were at least of equivalent diagnostic capability?
I know you can find a way to deny these things, but everyone else reading this, go through those questions and ask yourself if you can reasonably deny a single one of them. If you can't, and I know I can't, then you know we are at the end of the process.
For your convenience, here is another link to the FDA's 510(k) review process flow chart (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm), and a link to an SE letter from the FDA describing "Performance Data" to include a report from a radiologist about the quality of images from the application device as compared to its predicates (http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf ). If this is not iron clad proof that we are in the final stage then I don't know what is. Of course, who knows how long the final stage will take, but based on the data that IS (King Kong) Guru has posted, it hasn't been more than 183 days for any other device (including radiation emitting devices) since the new FDA has taken over.
It is very rare for the FDA to request comparison data like this. No applicant is going to do it without being asked for it. No FDA consultant is going to recommend an applicant do it without the FDA asking for it. The company in this SE letter was surely asked by the FDA for it or they would not have provided it. Our review was done in exactly the same way as this one, and this summary, by the FDA, comes straight from one of the applications that the FDA APPROVED, so there's no can of worms here.
This letter is actually proof that we are in the final stage of the review process, well beyond any possibility of PMA or NSE. Remember all the times that people have pointed to the FDA's 510(k) Process Flow Chart, and noted that at the very bottom, as the last step before SE is found by the FDA, the FDA may require Performance Data? And remember how all of those posters most familiar with the FDA process, myself included, have said: "hey, the radiologist review is the Performance Data that this flow chart is talking about." Well this SE summary from the FDA proves that. It proves that the exact same type of radiologist review done by this other Company and by Imaging3 is what the FDA means when it refers to "Performance Data" in its process flow chart. You don't get to that point on the flow chart until the very end of the process, and we're there. The NSE ship has sailed. The PMA ship has sailed. There are no other boxes between the Performance Data box and SE. The FDA didn't ask for it until the last round because we must not have been at the very end of the process until that request. We're there now. We're finally there.
Lest you ask for a "link" to the oft-posted review flow chart, it's in the iBox, but here it is again for your convenience:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm
The FDA follows an order in its review. If we have gotten to a request for Performance Data, which we know now from the FDA's own mouth means a radiologist review just like the one we submitted, then we are past all of the other questions and concerns. The only remaining question was whether the "Performance Data Demonstrates Equivalency." Well, the Performance Data was the Radiologist Review, and Dean said in the last conference call, that not only did it demonstrate equivalency, it actually found superiority. So we are done. Nothing left after that box.
Sano, I'm not sure how this could be any more clear. Don't just pluck a sentence out here or there. We gave you the link and we quoted the entire passage. Here it is again:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf
___________________________________
510(k) Summary for the O-Arm TM Imaging System (4101/05)
Assessment of Performance Data:
"A concurrence study was performed comparing images of the same anatomical structure made with a Siemens ISO-C C-Arm Imaging System and with the O-ArmTM Imaging System. The imaged subject was a cadaver allowing virtually identical sites to be imaged by both systems. Sites were selected to include common orthopedic procedure locations.
Thirty one pairs of images, including 3-D and fluoroscopic images, were evaluated. The fluoroscopic images were evaluated "live". Both the O-Arm and the predicate device have a feature that freezes the last image of a fluoroscopic series. The 3-D images and the "frozen" last images were submitted with the 510(k).
A radiologist evaluated the images during the study. He determined that for all image pairs, the images from the O-ArmTM and the predicate device are of equivalent diagnostic capability.
__________________________
"The fluoroscopic images were evaluated 'live.'" What other meaning can that possibly have? "COMON" Sano, you made a little hay of this issue. Your hay has been demonstrated to be wrong. Move on to other hay. You could always just talk about finances some more.
Shaka, also note that the conclusion of the radiologist in this report supports the notion that the comparison is not of the software code for SE, it's of the functionality of the device and intended use. The two devices had SE diagnostic capability.
Radiologist Review Included 3D Images:
BT, Dean has said publicly numerous times that the radiologist review included images in all of the DViS' various modalities, including 3D. If you go back to the conference calls and videos immediately prior to submission of the Radiologist Review, you will recall that Dean specifically said he was obtaining images from the predicate devices (multiple devices because there is no other single device that does all that the DViS does) in CT, 2D fluoro and 3D fluoro. He also expressly stated that he was arranging for images from the DViS in all of those modalities to be set up at the same angles, with the same level of penetration and all other settings the same in all modalities, including 3D. He also confirmed this post submission that all modalities were included.
The 510(k) Application Includes 3D Functionality in the Intended Use:
It's also absurd to suggest that the application does not include 3D functionality. The application is all about intended use, and if you look at the company's website, the 3D uses are all over the place. The FDA reviews the company's website as part of the process, so if their website talks about 3D functions as an intended use, you better believe 3d functions are included in the intended use statement of the 510(k) application. As further support for that, you should recall that the website used to talk about the DViS' use in mammography, but that was removed from the website when it was removed from the 510(k) application. If you want to know what the DViS 510(k) intended use statement says, just like Imaging3's website.
Sano's Link re: Live Review by the Radiologists:
BennyJ gave you your link in his very first post about the live demonstration. It's the link from which we were both quoting. The link is to the FDA's findings in an SE letter from a competitor's device, because the SE letter for the DViS has not been publicized by the FDA yet. It was provided as an example of how these third party reviews are conducted. It shows what the FDA asks for and what applicants give them, and that is a live demonstration. The DViS radiologist review was modeled after that one, and so putting 2 & 2 together, we know that our radiologists did a live review, just like that one. Go back to Benny's post and you'll have your link.
Perhaps I can help, Shaka, since my background is in dealing with the FDA.
A huge portion of the 510(k) applications the FDA reviews deal with improvements to existing technology based on changes to software to make a device faster or more efficient. The reason these applications all pass is because the FDA is not reviewing the software for SE. That's not the analysis. The analysis is whether the "intended use" of the new device and the predicate are SE and whether functionally they generate SE product; in our case images. In other words, are the devices intended to be used for substantially equivalent services and does the new device allow the medical provider to deliver the service as effectively.
There are literally thousands of devices already approved by the FDA intended to aid in diagnosis and to be used as visual aids in medical procedures. Hundreds more that do so by generating 3D diagnostic images. When intended use is established to be SE the inquiry then moves to whether the differences in software create any new safety issues, not whether the software is SE. So questioning whether the software is SE is not part of the equation.
It's all about intended use, functionality and safety. Dean's software is breakthrough not because it creates a brand new medical procedure. It's breakthrough because it dramatically increases the speed of an already existing medical procedure. So long as it's as safe as the existing procedure, actually it's safer because it's faster and reduces radiation exposure, then it passes.
Does that help?
How many interpretations does this have:
<"The fluoroscopic images were evaluated 'live.'">
I understand your frustration, but you are talking like the FDA breezes through other applications, yet here ours sits as an outlier in how long the FDA has taken. We are in the same boat as every other applicant. Was there something wrong with the devices for the thousands of other applications that took approx. 150 days - 160? If we get out past 185 or so, then it's at least fair to say that we're getting jerked around by the FDA in a manner unlike other applicants, but as of now, we are just getting jerked around by the FDA in the exact same manner as every other player in the industry. It stinks, but it is what it is.
Shaka, those applications that sit in no mans land eventually get a decision, and the timing of that decision is included in the data. For example, if 1000 get an answer (SE or NSE) in 150 days, but one gets its decision finally after 1,000 days, that 1,000 day decision would also be included in the data. The data does include those is the point. If there really are applications sitting out there for these long durations, they would be reported as such in the data.
Dean has answered this question no fewer than 20 times in conference calls, video updates, on Facebook, etc. As soon as they get word from the FDA, they will immediately pass it on to their SEC compliance attorney to help finalize the PR (e.g., tailor it with the exact language of the letter from the FDA, add the date, and anything else that needs to be done to finalize it). When it is finalized, whenever that is, before the market opens or after, a weekday or weekend, it will be filed with the SEC and a PR put out. The process should take less than 3 hours from the time the fax comes in to the time of the 8K filing and the PR. It will not first be announced by Conference Call, MoneyTV, Facebook, iHub, newsletter, airplane banner, etc. It will be announced within 3 hours of receipt by SEC 8K filing and a Press Release. This is the one thing there should be no confusion about.
I'd say the best thing to do to make sense of this is to take a look at the valuable DD that IS_Guru has been posting. The data that he has collected and analyzed shows that while the new FDA group has been very effective in reducing review times, nailing 150 days most of the time, it also shows that some of the more complex applications, including those involving the hot button issue of radiation emitting devices, take a bit more time, but not much more, than other applications. From the standpoint of when, I think the answer remains any day now. As frustrating as that is to hear, it is just as frustrating to write, but based on all of the stats out there, it remains true. From the standpoint of what the outcome will be, I'm more confident than ever that SE will be our answer. Again, studying IS_Guru's data from the new FDA team, you can see that NSE determinations are made much much quicker than SE determinations, and months quicker than we are in our process right now. That confirms Dean's expressed conclusion that if we were going to be found NSE and sent down the PMA route, it would have happened months ago. I don't know if I can talk people down from the ledge, but I recommend doing what I've done, which is just relax, try not to watch the kettle while you wait for it to boil, and just accept that it's going to happen and there's nothing that any of us can do to make it happen any sooner.
He said the "end of the year" because he believed they would have FDA Approval by the end of the year, he even says so in the exact same quote you pasted here. Come on, BT, stop playing this game. Luminary Sites were always always always going to follow FDA approval, and you have shown us nothing to the contrary.
I'm not sure why you are reposting all of Dean's old posts, but there is nothing in there inconsistent with what is happening now. As you posted, "Oregon Health & Science will not take delivery of their system . . . definitely not until FDA approval."
As for images, you're not still pretending that Dean hasn't posted images yet are you? That ship has sailed, BT. Dean has posted all over the internet numerous 3D images generated by the DViS, just like he promised he would do. Done. Give it a rest. In case you somehow missed them, here are a few links to 3D images generated by the DViS that Dean has made available for your viewing pleasure:
A video from Imaging3's website that features 3D Images:
http://www.imaging3.com/video_imaging3dominion.html
A video from a third party resource featuring DViS 3D Images from RSNA:
http://www.dotmed.com/news/story/11767/
The DViS 3D Orthographic Perspective Image was taken from the company website and placed in the ibox on iHub here:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=33897655
And of course, the 3D image of the hand has been on the Imaging3 home page for over a year:
http://www.imaging3.com/
Please tell me you understand the difference between a Beta test and fully deploying a device at a luminary site.
You need to go back and read and listen, BT. Dean specifically said these University and other high profile sites would get the first placements of the DViS AFTER FDA APPROVAL. You keep saying these luminary site placements never materialized, but they were never intended to "materialize" until AFTER APPROVAL, which, as we all know, has not happened yet. There are several high profile sites, including University hospitals, that are anxiously awaiting the opportunity to show off the DViS, and they will get their opportunity soon.
To save you the trouble of having to go back and look for Dean's exact words, here's his quote from a year old interview (proving this is not a recent spin or dodge, this has always been his position on the luminary sites):
"Dean Janes: Basically, we have our major milestone with FDA approval . . . . The next milestone will be distributing the product to what we call luminary sites. We will have a dozen, half dozen sites that will be high profile sites with esteemed facilities . . . . where we can draw from their strengths as far as having the exposure into the medical community. From those sites, we’ll use those as demonstration sites to have other facilities, potential buyers go and visit, call, do site visits to see this technology in action. . . . Now, we have many, many more sales lined up from there."
We have been hearing about them for a long time, but every time we hear about them, we hear that the DViS will go into those sites AFTER approval. Let's put this one to rest, can we?
The FDA conducts semi-annual audits of Imaging3's facility as part of it's remanufacturing business. Such an audit was not due for quite some time, but alas, they did arrive and they did conduct a 2-day audit of the entire facility. I know that to be true. I cannot say whether the audit related to the 510(k) application but I can say that the audit took place, it covered the entire facility, and it was due under the ordinary course of business and schedule. I can also say that such physical inspection by the FDA is not always done as part of the 510(k) process but is sometimes done, particularly for sensitive industries like Radiology. Wish I could tell you more.
Dean did get permission to post those images. He said he took a chance, and he did. He took a chance that posting the images would delay the process (and who knows, maybe they have). He was told he could post the images; i.e., that it would not violate the FDA's regs against marketing, but there was still the chance it would delay approval because the FDA could take additional time to review the images. Fact.
I have given no dates that have "fallen through." I provided dd about the FDA's track records and the FDA's goals, and have said a million times that these are NOT DEADLINES and there are NO GUARANTEES.
Have a nice day everyone.
Off to Bryce Canyon and won't be on the Board the rest of the day. Don't read anything into that. I've always felt like approval would come on a Friday, so maybe today is the day. Good luck.
Filings with the FDA are NOT PUBLIC unless or until the applications are approved. NO INFORMATION ABOUT PENDING APPLICATIONS IS AVAILABLE ANYWHERE ON THE FDA'S SITE.
Straight from the FDA's website:
Slide 45 of the video: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126288.htm
"We have this regulation about confidentiality really on the existence of a 510(k) application. We don't make it known publically that we have a 510(k) application under review, and we don't make anything known to the public other than those that we find SE. . . ."
I've said it before and I'll say it again, I'm not a trader or a flipper. I'm an investor. I invested in Imaging3 because I believe 100% in the potential of this Company. I'm certain they are going to sell the Company quickly after approval and that number will be higher than any spike on approval. I'm holding and waiting for the buy out.
I can see why someone who does not have any experience with the FDA would think that. They might think this is unusual to be held in the dark waiting like this. They might think something must be wrong or we would have heard by now. But sadly, this is the norm with the FDA. Actually, they have been even more open with the applicant than I have seen in the past. We know what they are asking and it is not any of the issues you have raised. This is just the run of the mill perils of dealing with the FDA. It takes time. It's frustrating. But at the end of the day, NSE is an extraordinarily rare occurence, so you just have to be patient and wait for the FDA's blessing. It should be any day now, but even if it isn't, it's still most likely going to be SE when it does come.
Correct, but I thought that was accounted for in the time difference between April 5 (when we actually sent in the application) and April 10 when we started counting (the day after receipt of the application was announced). It sounds like we didn't build in enough of admin days, per Mugs' post yesterday. That would explain why the FDA is getting answers back in what looks like 160 or so days and claiming that they are hitting 150 100% of the time. So we could still hear any day now and the FDA could still claim to have responded on time. Regardless, I'm not selling a share until buy out, so it's all just an academic excercise.
Sorry, pal. I was hiking the Narrows in Zion National Park today and was not around a computer. I expected to hear from the FDA by now, hoped we would have heard by now, but clearly we haven't. IS Guru posted some interesting data that shows recent FDA review time and there are a few in there just over 150 days and yet the FDA still reports hitting the 150 day mark 100% of the time. Looks like they count differently than the rest of the world. I don't know what to tell you. I'm frustrated, but also encouraged by that data that even when it looks longer than 150 days to the rest of the world, it's only been a few days longer. Still believe it's any day now, and still believe the outcome will be SE. Wish I could tell you something more.
Great dd. Thanks, Guru.
Everyone should take a look at the video presentation entitled: Medical Device Review Program Performance (Barbara Zimmerman)
This presentation provides a history of the evolution of the medical device user fee program. It also includes a detailed review of FDA’s medical device review performance under the current medical device user fee program which runs from 2007 through 2012 at this link:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm
The presentation is up on the FDA's site and set to be delivered in a week or so. Good information about the FDA's MDUFMA goals.
That Review Board has nothing at all to do with 510(k) applications. In fact, if you look into it, you will see that that Board is made up mostly of people who don't even work at the FDA.
The 150 day goal has been in place at the FDA since at least 2007. They have reported hitting the 150 day mark for the last 180 days, so we are well within the mark.
Well that's a little dishonest, don't you think. Neither BennyJ nor I, nor anybody else guaranteed anything was going to happen at any particular time. We simply reported what the FDA has done in the recent past. They have expressed goals (NOT DEADLINES) that they report on their website, and they track their own performance against those goals. The FDA's expressed goal is to provide a formal response to a 510(k) application within 150 days 98% of the time. Over the past 2 quarters, the FDA has reported that it has exceeded its goal of 98% by providing a formal response to 100% of its 510(k) applications within 150 days. Does that mean they are guaranteed to provide Imaging3 a response within 150 days? No, but it is a pretty good sign. Did BennyJ or I guarantee that Imaging3 would get a response within 150 days? No, but I'm still pretty confident we will. When Madtig reports that the trend line looks positive in one of his charts, has he guaranteed that the PPS is going to continue to rise? No, but he believes his technical analysis suggests that it will. Don't distort what other people have said here. If you want to make your own guarantees, go right ahead, but I have guaranteed nothing. I have simply reported FACTS, with links to factual resources to back up those FACTS. Those FACTS are undeniable, but they also DO NOT GUARANTEE anything about what is going to happen for Imaging3. Don't put words in my mouth.
It is outrageous for you to sit here and say that was a lie. We all know excactly what happened. We were down to 1 question, and that 1 question was about the label, and just as that 1 question was answered and the application was set to be approved, the Reviewer, the Reviewer's Supervisor and the Director of the CDRH were all fired and replaced as part of a total overhaul at the FDA and in the CDRH. That was darn bad luck, but not a lie at all. It is so inappropriate for you to say things like that.
30 was based on Dean's experience and what he continues to talk about from the past. 90 and 150 days have been the FDA's MDUFA goals since 2007. It's not something that's been made up by posters on this Board. Go to the FDA's website and verify it for yourself.
These are very good points, gentlemen. The FDA takes its performance against its internal goals pretty seriously, but they just need to justify to themselves and to Congress that they are meeting those goals. So they could easily "make the decision" within their guidelines, but not communicate for a few days. What we have seen lately is that applicants ARE HEARING within (often right at) 150 days, but there is no deadline for them to communicate the decision. They will not report it publically before communicating it to the applicant, but they do not have the same SEC-driven 72 hour requirement that Dean has. These days they are most often communicating SE determinations to applicants by fax, so it stands to reason that we'll know very shortly after they decide, but there is no guarantee of that. While I believe Sept. 8 is the 150th day, I'm looking at next week in general as when I expect to hear. Or today.
If you need changes, and after the changes you get SE, then you still got a final determination of SE. That counts. In fact, virtually every single 510(k) application requires changes prior to an SE determination. It is extraordinary for a first submission to be approved without some changes, without some AI request. The analysis is whether you get SE or NSE as your final determination, and 97% of applications get SE as the final determination and 3% get NSE as a final determination. As we have experienced better than most, some applications take longer than others to get there, but all that matters to longs is SE vs. NSE. I'm not a flipper or a trader trying to make $500 on a flip here and there, I'm here for FDA clearance, whenever that comes (and I believe it comes by next week), and I like my chances of getting SE (97%) better than the chances of the fearmongers who predict NSE (3%).
Cpbball, the FDA guidance contemplates that applicants will take some short amount of time to respond to their informal information requests, and that if the agency feels like the applicant is taking too long, they will send a Hold Letter. They did not do that here, which makes sense since it was only 2 weeks, NOT a "few weeks," and since they were not without the application during those 2 weeks. They didn't ask for Dean to submit the annotated version so it's not like they set the application aside and waited for his response, it wasn't even respnosive to any request, it was just done on Dean's own initiative to make the road map easier to follow. The facts are clear and they are repeated by the FDA over and over in black and white on their website, in the presentations they put out to the public and in practice when you deal with them... unless there is a formal written letter requesting AI, or a formal written Hold Letter following an informal request, then the clock DOES NOT STOP. Now all that being said, whether the clock stops or not, there is still no guarantee that you hear at any given time. They have their goals and their guidelines, and the "new FDA" has done a commendable job meeting their goals, but nothing with the FDA is guaranteed. So you may be right that it doesn't come by the 8th, but that is NOT because the clock stopped. The clock did not stop. I still believe we will hear by next week.
I've given you all the facts already. My predictions are not facts for the history books. The FDA's own self-reported statistics are facts for the history books. 97% chance of SE as a final determination is a fact. 3% of NSE as a final determination is a fact. 90% chance of a formal response within 150 days is a fact. What you are asking from me is by definition not a fact, so I am not inclined to indulge you, especially because of the way you have treated me in the past.