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I call bs.
Longer.
What information do you have to prove that assertion?
U2 Chris
A better question is why….unless you’re a short who’s covering.
Very nicely said!
I have to admit Alwaysintheknow, your post is a bit more encouraging than Sporty’s. We don’t need this at this time.
“Especially since it always says there is no certainty that the PMA will be granted. JMO”
It’s standard legal jargon/disclaimer that although technically true, has no bearing on how/if I decided to invest in this company.
Having said that, I believe that it’s “very likely” that the product will be approved. In fact at this point in time, I would be astonished if HemoStyp was not granted PMA approval.
It’s my due diligence and knowledge/experience of the clinical data that gives me the confidence of the outcome along with the proximity to the endgame. Of course, I’ll provide my disclaimer of “IMO”.
lol
It’s hard to say but I believe that MM’s are holding the stock in this narrow range and there has been a bit of selling on top of it. This is pure manipulation as I see it. When the FDA finally approves; this all will go away…finally.
If the stock does dip into the .30’s, I do plan to pick up more shares, as well. I view that as a rare opportunity to add at very attractive levels.
Well today was sunny and hot and maybe tomorrow is gonna be the same…lol
I share your opinion, sir.
Muted response so far today. I do believe that there is a lot of “sausage making” behind the scenes.
“Time for UHP regulatory consultant to do his job:”
I think the “regulatory consultant” should be shown the door. They should have better prepared the company for this meeting. The results speak for themselves.
Its always 20/20 in the rear view mirror but, it’s now obvious that they need to complete the final requests from the FDA and that then they will get the approval.
I’m frustrated that they weren’t prepared with with what the FDA wanted to see for the meeting on 7/13. If they would have presented the information requested then HemoStyp would have been approved for internal surgeries. They need to get this right.
All company walk on “egg shells” when it comes to the FDA. It’s the nature of the beast their dealing with.
B. Thom seems to be doing all the right things. He isn’t the communicator that Beplate was and I think that’s a good idea when it comes to the FDA.
Although, it might not seem like there’s enough info coming out; Thom plays it conservatively and that benefits shareholders IMO.
Let’s see what happens next week. I am very optimistic.
You people are real dirt balls.
There should be many companies interested since there are many competitors. J&J has the most to lose since SurgiCel is the “standard of care” but was soundly beaten in the head to head trial. One would think that they have to be in there with an offer.
The MM’s are holding the price down IMO.
Yeah, everyone is focused on the meeting Wednesday. Don’t expect to hear anything that day. If there is news coming I’d think it’s Thursday or after.
Good for you buddy.
It’s hard to believe but we’re only 4 days before a “potential” “approval” or (more likely) “approvable letter”. To my friends who are long the stock…I applaud you for your tenacity and resolve with a stock that has been through the “ringer”.
There have been “those with a different opinion”? (HA!) but, in spite of that, we persevere! We have gotten to a crucial point in our journey and we are on the cusp of success.
I believe, more than ever before, that the FDA will approve…if not Wednesday then, soon after. Since the timing of that approval has been a moving target, still…I do believe that each day we get closer.
Wednesday is the meeting; I’m talking “probability” of good things happening very soon. It’s a “gut feel” but all my instincts and experience tell me this could really be it. I’m excited about our expectations and wish us all the best outcome!
Cheers to all “Longs”!
C’mon man! Don’t tell me you haven’t read the study?! If you did, your answer would in black and white! READ IT!
Right you are, band aid! That’s the one thing that surgeon’s are risk adverse to…
“lawsuits”!
Excellent points SportyNorty especially the reference to the recently given RSU’s with the qualifier that they vest with a change in control. Obvious what’s going on.
Cheers!
I thought it was self explanatory but here goes….if they get the approvable letter on 7/13 then…my experience is that the FDA will give final approval in 30 days.
Again, that’s what I saw many times over the years. I hope that this applies to Med-Surg products and that this aspect of FDA methodology still exists today.
I’ll also say that I never saw a product “not get to approval” after receiving an approvable letter. Hopefully, that clarifies.
Just one thing I didn’t mention…typically, approvable letters” come with an FDA (self imposed) 30 day expiration.
GM band aid, I think the most likely outcome is that the FDA gives us an “approvable letter”.
This gives the company the necessary time to work with them on the indication/labeling and any other loose end minutia.
The “approvable letter” is their indication that they will finally approve. It’s standard procedure, at least it was on the pharmaceutical side where I was.
So did I. The MM’s kept moving the ask but I got the shares.
Placed a limit order. Doing some bottom fishing. Have a great holiday weekend to all longs.
To be honest, I like your numbers better than mine. I sure hope you’re right. Will gladly have a plate of crow.
Excellent post.
Well…”it depends” …it depends on how the indication reads. It depends on if there are buyers that step up to the plate right away…it depends on timing…market conditions…and on and on.
My best guess…and please understand it’s a “guess” is that the product is so superior to what’s out there that there has to be big guys interested. J&J has the most to lose so, they have to be a force to recon with.
My guess…we shoot to $2.50 to $4 and an offer comes in. I don’t think there will be only one offer. My buy target is similar to SportyNorty. $7-$10 or more…depends again…on the buyer and how they value the company and potential counter offers.
At any rate, I feel good that we will be north of $5. But then again…it depends.
GLTA!
Nice my friend! I plan on picking up a bit more as well. Not too long till fireworks!
Yes sir, I’m sure that you’re gonna look back in the years to come and feel great about your equity decision.
I’m gonna add…. Like SportyNorty said…this is a once in a lifetime “friends and family discount.
The FDA meeting is a little more that a couple of weeks away. I am well positioned like most other longs. I don’t necessarily think that the approval comes on the 13th but within a short timeframe just after.
For example, if they get an “approvable letter” that can mean that the final “approval letter” will come in 30 days…like I’ve seen so many times before I’m my past business life. Very exciting times.
It’s possible.
Correction to rogue spellcheck…I couldn’t agree more, Sporty!
Could agree more, Sporty!