Post by
N0taP00p on Feb 02, 2023 9:57am
Interpretation of latest NR
So help me understand this. This NR clearly implies that as of TODAY, the needle hasn't moved for CR data. Still at 28% for 450 days. All of those additional CRs that we were expecting (converted from PRs) either didn't happen or they STILL are waiting for someone to complete that determination based on FDA guidelines. For some reason, they included numbers with this NR. Please don't tell me that they meant something else while they stated something else. If they say this is the info as of today and it is interim clinical data, nothing has changed yet. They are publishing everything except timing of when they expect to submit to the FDA. Anyone else smell delay? Tell me I'm wrong please and why.
This almost exactly mirrors what Titan Medical used to do. News release upon news release about presentation of their wonderful technology at various conferences. But the FDA submission always got pushed for one reason or the other. I always used to wonder why a big medical devices gorilla just didn't buy them out. Medtronic ended up buying some key IP for $10M and that's it. I'm worried that we'll get a small asterisk in the quarterly report coming end of this month to say they've pushed the data submission out. Do i want to be wrong? Yes. But the opaqueness worries me already. All IMHO.
Comment by
blackjack0 on Feb 02, 2023 10:05am
Not sure why I waited so long. Ignore!!
Comment by
ScienceFirst on Feb 02, 2023 10:06am
N0ta ... You're wrong. And you don't understand how the industry works. There are rules for these congress. Go see them.
Comment by
Donein25 on Feb 02, 2023 10:18am
I think you are reading too much into this PR. The #s quoted by Dr. Mandel are from the last read out in November. That's public knowledge at this point in time. It doesn't imply anything about the upcoming data expected later this month.
Comment by
ScienceFirst on Feb 02, 2023 11:01am
We recently discussed that submission to the FDA is not material. Never seen any examples of biotechs announcing submission. But the FDA response, positive or negative, is material.