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So now you’re saying that the company is deliberately misleading shareholders?
I think not...
Most definitely!
A friend who is a shareholder brought to my attention that the 30 day FDA response should probably be counted as “30 business days”. This makes sense to me and if you use October 1 as the starting point then 30 business days would put us at November 13th.
So...my bad for thinking that you just use the calendar days and let’s see what happens next week.
Have a great weekend...longs and GLTA!
While I agree with you that the FDA has dragged their feet with this product I believe that the fact that they stated ...there will be a response in 30 days...is a different kettle of fish IMO. They’ve imposed that timeframe on themselves.
I really do think that they will stick to that timeframe. At least, when I dealt with them in the past....they always responded. We may have not liked the response but they did so as they promised.
Today, everything is gone to hell with COVID, the politics of the day, etc. So, that’s my disclaimer. It’s really anyone’s guess as to when they will respond.
The one thing that we can hang our hat on is the data and the huge boost in credibility/visibility we got from the Journal of Wound Care picking us up for publication literally, next week.
That indicates to me that the approval is a done deal but, we don’t know how good the indication will be spelled out. The better it is the more valuable our company will be. I’m very excited at the prospect.
GLTA!
Me too buddy!
Yeah, I hear you band aid. It’s coming and hopefully the FDA sticks to their 30 day response. But, it really doesn’t matter which day they approve from a big picture standpoint; just that it happens as we expect it to.
My experience is that when the FDA says they’re gonna get back to you in 30 days...they mean it. Having said that; we are in interesting times and you could be right.
What roadblocks?
It’s shorts and sheer stupidity!
You got that right. It amazes me as well that this information is staring them in the face and there are people even selling.
You, I and the other longs have got it right and will reap the benefits and, this will start to happen very soon ... like this week...IMO.
No matter...our time is coming soon enough.
Hey BFU, this journal is like the New England Journal of Medicine but for wound care. Very prestigious and a real feather in the cap for the company.
Peer journal review validation. The story continues to build!
Yeah, it’s the same information. There was probably some nuance that was missed or a reiteration of the results. I don’t know for sure.
MHO we get approval by EOM.
So, under secondary outcome measures...
100% of HemoStyp patients achieved hemostasis at 2 minutes whereas SurgiCel was inferior. They only had 94% at 10 min.
We win hands down!
Yes, there is. See below. It didn’t copy the format but time to hemostasis for HemoStyp was 36 sec. vs. 67 seconds for SurgiCel (avg)
Secondary endpoints were positive as well.
HemoStyp Surgicel
Hide Arm/Group Description:
Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.
Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
Overall Number of Participants Analyzed 118 118
Median (95% Confidence Interval)
Unit of Measure: seconds
36
(31 to 47)
67
(57 to 89)
2.Secondary Outcome
I’m with ya brother!
That villa in Italy sounds really nice. I worked in Italy quite a bit. I’d be looking on the Amalfi coastline...specifically Positano.
It’s a great part of the world.
All of the above. The company presents their case to the reviewers for what they want in the labeling and there is a negotiation of the wording based on what the FDA will allow.
Don’t we all...
The study indicated superiority. The question is ...will the FDA agree to allow superiority in the labeling. We don’t know for sure until we see the indication.
Don’t be surprised if the FDA uses all of the 30 days to respond. That’s how they roll. In addition, during this “wait period” the FDA is in discussions with the company regarding labeling. If the approved labeling states “superiority”...strap on your seatbelts for a big move up. MHO
The shorts are playing a dangerous game. We know the FDA will respond in less that 30 days so, when they get caught on a gap opening higher...they will take it in the shorts just trying to cover. It will be a wonderful thing to see...yes wave...karma!
The CEO just said otherwise in the latest pr. Why would he put that in the pr if he didn’t believe it? Of course, the FDA could ask them for more testing but this company has been working closely with the FDA from the beginning of the CTQ program. I would think that the FDA must have communicated that timeline to them.
I honestly don’t know who the company could be but I agree it could be J&J. They’re about to lose a chunk of market share, quickly. If they had HemoStyp to transition to that would stabilize their share and grow it over time. Seems like a logical choice.
Couple of good posts, Always! Thanks.
Thank you Dr. Andrew for your thoughts. I look forward to approval and buyout/merger or whatever lies in store for this great product and company. I also look forward to reading the clinical study when available since that will fill in the story.
GLTA!
Trust...you are exactly correct. If superiority appears in HemoStyp’s “indication” then it will quickly become the “standard of care”.
Surgeons will have to start using it for fear of a lawsuit if something goes wrong with a surgery i.e., a patient bleeds out or there is some surgical complication that arises that could have been prevented by using HemoStyp. I would imagine that the move from SurgiCel to HemoStyp would be immediate.
That’s acceptable. We’re both on the same team. There’s no need to be combative.
Thanks BFU and band aid! I feel the excitement!
What’s important to me is that the FDA has notified the company that once they make their final submission then a decision on whether to approve or ask for more information will take place in 30 days.
IMHO we will see approval by mid October or sooner.
For those that doubted my saying that approval is in the near term......I told you so!
It will be the former. Hang tight.
Thanks buddy! Another “arrow in the sling”!
Hey trust, someone (plural) wants shares bad. That’s actually a good sign. They can’t have any of mine; I’m holding on with both hands! We’re close.
Chris, I think you will be happy with all your buys when this comes in. Good for you.
Yeah, no problem trust. You and maybe a couple of other people on this board are the ones I’ll continue to communicate with.
BTW ...”band aid” is one of the good guys.
I’m patient and I’m long. It will be epic!
Ignored!