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Hey bandaid, here is the specific FDA language regarding action on a PMA filing:
FDA Action On a PMA
Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:
an approval order under §814.44(d),
an approvable letter under §814.44(e),
a not approvable letter under §814.44(f), or
an order denying approval under §814.45.
For those interested in the minutia of the FDA’s application process:
Steps in the PMA Application Process
Filing review:
Statistical review for filing
Review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
PMA filing decision
Day-100 Meeting
Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is may be conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.
Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)
Substantive review coordination and completion in areas such as:
Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
Nonclinical Studies
[Microbiological, Toxicological, Immunological, Biocompatibility, Shelf Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue, etc.)]
Clinical Studies
Panel Meeting Decision and Mailing (if panel meeting is appropriate)
Panel Date (if appropriate)
Transcripts Received, Reviewed and Placed in Administrative Record
QS/GMP Clearance
Final Response for GMP/BIMO
Final Decision Memo
Approval Package
Approval Order, SSED, Final Draft Labeling
Hey bandaid, good to see you back as well. That’s my best guess based on available public info. I could always be wrong so, fingers crossed that we’re close.
I hope that the requests from the FDA have ended. If so, then the final committee will have the completed package and render a vote.
Glad to welcome another villa owner to the neighborhood. So many incredible places in Italy. It’s my favorite country. Spent a lot of time working there.
Cheers!
Thanks for sharing that. You are true to your convictions and I respect that. And, I hope you’re right. Maybe I’ll buy the villa next to yours in Italy.
As a postscript to your message…I hear ya referencing the FDA seemingly endless requests. I have a relative in a management position with a big company that has OTC products that require documentation to the FDA. He said that this is a normal request when dealing with them.
I meant buyout price…
Valid point…also, you gotta think the Covid played a role in delaying processes.
What is your price target, today…if I may ask?
Hey trust, yeah he was right. I like you were fed some erroneous stuff.
Short answer…yes. The FDA self imposed 180 day time to decision is around 11/5 if you use May 5 as the start. In any event, it will happen in the near term by sometime in November. IMO
So today they announced another HemoStyp format to be evaluated. A “trauma application” to its line. That’s now 4 formats:
1. HemoStyp gauze
2. Hydrocolloid
3. A patch dressing for post dialysis
4. Trauma format
Each additional application represents added value to the company with this “suite of offerings” to the med/surg community.
UEEC is building value for the company and this will eventually be reflected in the stock price.
GLTA!
Those shares I bought at .895 are looking real good this afternoon. That was a gift. Personally, I think we move up from here.
I hope…
I’m buying like crazy.
It’s common for investment funds to get a discount. That’s the way the world works.
Don’t get me wrong….I hope he’s right too!
No criticism coming from me. I agree with most of your post. The PPS on approval will go to…in my way of thinking $2-$4. The big prize is the buyout which will put the stock definitely higher.
I’ve thought long and hard about what will be paid for this company if they are bought out lock/stock and barrel. I used to think $10-20 but that is unrealistic in my view. Ive settled in on my pie in the sky # and that’s between $$5 and $10. Let me say that I really don’t know what it will be…it’s just what I think may be offered…eventually.
I too am a long hauler and if we go it alone….the eventual price will be way higher over time but, I don’t think that’s what the company wants to do. As you say, we’ll see.
Either way we will profit and no matter how much it is….there will be no complaints from me.
Agree with all of your points. My thinking is that there are acquirers waiting in the wings for the approval before they pull the trigger. The company has said on many occasions that they have talked to several potential entities. When the approval comes, there will be a lot of things happening relative to the company’s future. I can envision lots of press releases. IMO
On the drug side of the business, if you get an “approvable letter”, it usually came with an FDA self imposed 30 day action/response. As you relayed, it would be taking care of some
final details before approval. In my experience, if the FDA sent an “approvable letter” it always was followed by the approval.
Wow, a reversal. Honestly, you made the right move. Sorry for jumping on you.
I’ve always known about the FDA’s self imposed 180 day timeline for decisions post acceptance of an application. That’s all I can say about that.
Nicely done…
My guess would be an answer as soon as this month thru November. It depends on the FDA not asking for any more documentation. If everything is in, then we’re just waiting for the answer.
We longs are kindred spirits. We stick together with this investment. We will have our day of celebration.
Actually, a stock swap is preferable from a tax standpoint vs. an “all cash” deal. With stock swap there’s only one taxable event…….when you sell.
I agree….I mean…he already has 35 million shares. Does he really need the extra 400k?
You are so right!
So Doug Beplate bought 400k shares @ .97/share. As a company official, he has to report this to the SEC. This is great news because it proves his optimism in what’s to come. It’s a very good sign to shareholders. IMO
It was Beplate who, I believe, purchased the shares @.97 per.
8/6 SEC filing.
Beplate is Chairman of the Board; Brian Thom is CEO.
It would also follow that, if J&J thought that PerClot would be a serious competitor; they would have bought the company.
Very good possibility…they have the most to lose.
I’m reading the PI for PerClot now. It seems like a real tricky product to use. It has several precautions and warnings.
You never know…Baxter seems to be buying up companies in this class of MedSurg offerings. They could still be interested. We will have to wait and see.
PerClot is a small niche player that would be no real competition for the comprehensive line of HemoStyp agents they will be bringing to market. IMO
Yeah band aid, we might have to meet up with trust at his Italian villa to celebrate! I’m patient…
Nah, not yet. We need something significant to occur like approval. Until then, I believe we’re in a trading range.
It’s obvious the day trading going on for those who are clueless of this stocks potential. But, UEEC has been on a steady climb of late and it’s gratifying to see.
And yes, I’m sure management has their hands full trying to negotiate the wording of the indication and other details. It’s an exciting time and I’m psyched about our prospects.
That will fulfill the need …for some…