Thanks. Now here are my thoughts:
Here are the negatives:
First, I was hoping to hear that the package was submitted to the FDA today. It wasn't.
Second, they have not completed gathering all of the data needed for the Radiologists to conduct their review. They are close, but not complete.
Here are the positives:
First, Dean expects to get the package back to the FDA by April 5 at the latest, which is, at most, a window of ONLY 18 business days. If this thing was going to double on resubmission tomorrow, it will get to the same place in one or two weeks . In other words, whether it's today or 2 weeks from now, I suppose there's no real difference.
Second, Dean has been in much more regular communication with the FDA this time around. He has pushed them to say whether they have any other questions or issues, and, while the FDA is going to do what its going to do, so far they have not identified any new issues. Accordingly, we can expect approval if this package checks out alright. And he still maintains that we should expect an answer from the FDA within 30 days. So most likely, we're looking at approval before the end of April.
Third, Dean pretty much went as far as he could go without flat out saying it... Toshiba wants to buy this product.
Fourth, Dean explained in as clear terms as he has to date, why the images are not on the site yet, and if the FDA gives him the green light, he will put up the images used for the radiologist review after it is submitted. He als reiterated, as he has in the past, that there are no technical problems at all with the device or the images.
Fifth, Dean confirmed that he does not the PMA route as even a possibility, and that the FDA has not even mentioned it.
Finally, Dean explained that we will learn about the resubmission by a Press Release, and we know this thing is going to rocket up upon that announcement. Accordingly, there will be zero opportunity for people to buy back in on the way up, so that will reduce the number of people selling tomorrow and sitting on the sidelines.
So overall, I'd say this was a very positive call, we are fully armed with all the information we could possibly ask for, and the path forward seems to be clear of obstacles. We may see a dip tomorrow because people expected to hear that the package had already been submitted, but in my opinion, anyone that sells is very short-sighted. I do not expect there to be any staying power to a dip. I expect we will be sitting here around .70 or higher at the end of the week, and we'll rocket up to 1.50 the minute the PR comes out.
Stay long.
AI
