Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Just waiting to see if VCEL becomes profitable this quarter as ceo mentioned on the CC in Dec 2016, without respect to Ixmyelocel-T
I can't wait for the CC in November.
I think The FDA will give us accelerated approval for Ixmyelocel-T
with no phase 3 needed. We find out soon in the coming 60 days or less.
I would think that that is a material event that has to be 8-K and not wait to CC to reveal it.
I am waiting for the Baker Brothers to position up in VCEL
http://www.nasdaq.com/quotes/institutional-portfolio/baker-bros-advisors-lp-596248
Very large healthcare tute
lasers, awesome, about time, shorts are on notice 4.80 on board
I understand now, when you posted that 10, there was no reference if it was 10$ 10M or 10B,, just a 10, and vague
Ixcell has its own market cap, as to MACI, and as to Epicel
I got to go shopping at the trap store for a bit, either later today or tomorrow I will look and see if I can find what you are
mentioning.
If you can search back that would be helpful. I have 100's of articles that circulate and memory is not grabbing right now.
Maybe lasers has some insight on this.
Yep, and if FDA accelerates approve IXCELL and news hits CNBC, we will be in double digit land like a mofo :) Volume will be through the roof on this ... first in history ...stem cell treatment for the heart DCM, which as of now there is NO CURE
I don't understand this statement you made in your post
lasers, do you think we will get a pps lift when United Health and Anthem has the CPT codes updated, or will that be a non-event
and is your 10-15 on MACI alone ?
and is your 40 in 18 mos on MACI alone ?
All the FDA has to do is wink an eye to accelerated approval, even if it wants to see the Feb 2018 final safety of the crossover study, and we/VCEL are golden, as you say
I totally agree with you.
I would like to see some insider buying kicking in, why wouldn't they or are they in quiet periods because of this B meeting with FDA ?
Getting excited about FDA meeting, just rereading the Q & A regarding Ixmyelocel-T from Q1-17 CC
https://seekingalpha.com/article/4071673-vericels-vcel-ceo-nick-colangelo-q1-2017-results-earnings-call-transcript?part=single
Kevin DeGeeter
Hey. This is Kevin. Thanks for taking my questions. Congrats with regard to the RMAT designation. Can you clarify with regard to the potential for accelerated approval? Do you anticipate that that could be based on the completed 2b study, or how should we interpret that language in the context of a large existing database around ixmyelocel-T?
Nick Colangelo
Yes. Thanks, Kevin. This is Nick. And I’ll start and I’ll turn the call over to Mike Halpin, who I’d like to introduce as our new Senior Vice President of Quality and Regulatory Affairs.
As I mentioned earlier in the call, the standards for getting the RMAT designation is, obviously, treating a serious unmet need and then preliminary clinical evidence indicating that the drug has potential to address that unmet need. In terms of the accelerated approval, it can be based both on surrogate endpoints as well as data from a meaningful number of clinical sites. So, we certainly believe that there is a basis for engaging with the FDA in discussions around an accelerated approval based on a Phase 2b study, as we conducted that study at nearly 30 sites in the United States.
Mike Halpin
So, I think our next step -- this is Mike Halpin, would be to have a type B meeting with the FDA to explicitly discuss the accelerated approval strategy with the Phase 2b results we currently have and the other clinical data that currently exists for the product and explore the pathway.
Kevin DeGeeter
And along those lines, can you just comment with regard to business development strategy for ixmyelocel-T in the U.S. and in other ex-U.S. jurisdiction, specifically Japan? Do you want clarity with regard to, for example, in the U.S. that may come from this type B meeting before pushing more aggressively perhaps and partnering, or are these sort of independent track considerations with regard to business development and regulatory strategy for ixmyelocel-T?
Gerard Michel
Kevin, it’s is Gerard. Certainly, assists and conversations we’ve been having and I think will continue the conversations, I do think though it would be an inflection point getting the information out of the type B meeting. So, right now, what we have is, the table set for a lot of opportunities in terms of accelerated approval, till we have the meeting with the FDA, we’ve been entirely clear what the path is. So, I expect accelerated discussions once that meeting has occurred.
Kevin DeGeeter
And then, just one last point of clarification with regard to discussions outside the U.S., I think some of us have looked at regulatory environments, for example, in Japan. I thought that there may be faster pathways to partnering in certain geographies outside the U.S. Is that kind of consistent with your current business development focus or should we think about the U.S. is now being perhaps a higher priority or faster path for potential marketing or partnering?
lasers, how many MACI procedures would it take under the current share structure of 32.8 o/s would it take to reach $1 EPS, would 1400 do it? or less, or more?
I know ceo stated 20k per year potential market
Matching a face up with a VCEL MACI surgeon article
https://news.vanderbilt.edu/2017/09/14/novel-knee-surgery-utilizes-patients-regrown-cartilage-cells/
https://vanderbiltboneandjoint.com/doctors/scott-arthur/
VCEL
Somebody should ask these questions on the next conference call.
$VCEL ... Knee cartilage repair market worth $2.7 billion by the end of 2023
https://www.whatech.com/market-research/industrial/373816-knee-cartilage-repair-market-worth-2-7-billion-by-the-end-of-2023
VCEL
lasers, have they ever tried MACI on the hip ?
https://www.sbnation.com/2017/9/8/16276550/isaiah-thomas-hip-injury-update-arthritis-cartilage-cavs-celtics-kyrie-irving-trade
I have to fully agree with you. and FYI Vericel mentioned in these article
https://www.pr-inside.com/europe-cartilage-regeneration-market-to-reach-216--r4634681.htm
https://www.medgadget.com/2017/09/north-america-cartilage-regeneration-market-worth-usd-290-70-million-by-2021.html
Yep, sure it will spike on news, but the big money will be on a 3 yr hold or longer, unless we get bought out in between, but will reevaluate in one year from now on position holding period, IMO, this stock is golden.
Time will tell. Soon we'll get new upgrades with new price targets.
Wow, now that is a first, maybe a signal to fire up the engines
Down to 8 jobs now http://vcel.com/careers/ I have never seen VCEL go a whole quarter without any press releases, they are keeping very low keyed pre FDA meeting this month.
Bummer for us longs hungry for news, but very smart on their end.
Accelerated approval, LET ME GOOGLE IT, LOL, without image of course
Looks like a whole new topic to talk about
https://www.google.com/search?source=hp&q=fda+Accelerated+approval&oq=fda+Accelerated+approval&gs_l=psy-ab.3..0l4.2638.6860.0.8058.9.6.3.0.0.0.191.1068.0j6.6.0....0...1.1.64.psy-ab..0.9.1107...0i131k1j0i10k1.nRp5F2j3mEo
Maybe the new general manager will trade the FLCR otcbb shell company for a 50lb bag of popcorn and a tub of butter
$VCEL and this
MILITARY $121,580 Federal Contract Awarded to Vericel
http://www.4-traders.com/VERICEL-CORP-18635051/news/Vericel-MILITARY-121-580-Federal-Contract-Awarded-to-Vericel-24895796/
VCEL
$VCEL lasers, you see this, MACI on the ANKLE, lesion of the talus
From the NIH.gov site
https://www.ncbi.nlm.nih.gov/pubmed/28587484
https://www.aofas.org/PRC/meeting/Documents/7yearfollowupofmatrixinduced.pdf
https://www.google.com/search?safe=strict&as_qdr=all&source=hp&q=lesions+of+the+talus&oq=lesions+of+the+talus&gs_l=psy-ab.3..0i22i10i30k1j0i22i30k1l3.894.4366.0.5206.20.20.0.0.0.0.148.2027.8j11.19.0....0...1.1.64.psy-ab..1.19.2022...0j0i131k1j0i3k1.Gx_mVUA7XjE
VCEL
By then I expect VCEL will be 2.8 Billon of that 60.8 Bil
Global Tissue Regeneration Market expected to exceed more than US$ 60.8 Billion by 2022
Yes, Ixmyelocel-T, is a patient-specific multicellular therapy, and if my memory serves me correctly, Ixmyelocel-T has been in development since the mid 1990's, originating from the scientist from the University of Michigan, and got ophan drug status back in 2009, and was renamed Ixmyelocel-t in March of 2011, or something like that.
Holy Mackeral, lasers, I should sell my body parts, I could make a lot of money.
I was thinking the Ixmyelocel-T was pricing in at 143K from one of the previous conference calls, but I can't cement it.
Comments about this can be found on the video just posted on the VCEL twits thread, go check it out
https://stocktwits.com/symbol/VCEL
vcel
VCEL we will get FDA accelerated approval on Ixmyelocel-T based on that FDA letter I just rehanged from the brianIQ from another board
The tea leaves are quite clear. JMHO
Like Doc says, the shorts are going to need Epicel soon.
Great FDA letter posted by BrianIQ from another board, surely backs up that Bloomberg article recently pressed, VCEL/ASTM has countless years and 100's of scientific research articles, on Ixmyelocel-T, takes 20 years to take a drug to market and we are on time, this year or very soon
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm
Efficient Regulation
With regard to our regulation of these products, I want to expand on the need for bright lines and appropriate oversight to accommodate the good actors working on genuine science.
As we work to protect Americans from the bad actors, I’m equally committed to doing all we can to help bring to patients more quickly innovative, scientifically proven regenerative cell therapies. For this reason, we’re developing a comprehensive and efficient, science-based policy with the aim of accelerating the proper development of these products.
That is not at all what I posted, please re read.
That bold post was from the 10-QSB with link.
I clearly stated the FDA meeting is in 1 to 3 weeks from now.
per the most recent conference call
or delisting, who is going to file the sec 10Q's and 10K now, let alone pay for them
they put the old general manager in on officer postions, that is not good.
I see this going to the sub four digits, but what ever, someone close to company dumped in forehand knowledge and got 4g out at least
maybe foreclosure is coming who knows
maybe the new/old general manager will put out a letter to the shareholders if that 25 dollar an hour employee ever heard of one
OR, MAYBE THEY ARE SNOWBALLING US AND A REVERSE MERGER IS COMING IN? NEW COMPANY NEW ASSETS NEW TALENT
FLCR
$VCEL And the beauty as you and lasers and all us know is this is going going to occur in the next 1 to 3 weeks or so, what great time to be a VCEL long :))))))))))))))))
We are scheduled to meet with the FDA later this year to explore possible accelerated approval options available under an RMAT designation.
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=12221353&RcvdDate=8/9/2017&CoName=VERICEL%20CORP&FormType=10-Q&View=html
VCEL
older Ixmyelocel-T article again, read the last two paragraphs
http://www.dent.umich.edu/sites/default/files/About%20the%20School/Department/POM/Kaigler%20et%20al%20AdvDrugDelivRev.pdf
older article but on topic = 192 Safety and Efficacy of Ixmyelocel-T
http://www.jhltonline.org/article/S1053-2498(12)00205-7/fulltext
Tell me we ain't going to be a 10x if Ixmyelocel-T gets FDA accelerated approval
Go ahead, convince me
As the doc says, the shorts are going to need Epicel very soon if we get FDA accelerated approval.
Was that study updated by Vericel for the FDA class B meeting?
Notice the market size in that study
"affecting 5 million patients in the US, with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the leading cause of hospitalization in persons over 65 years of age with cost exceeding $29 billion annually."
View of NCT01020968 on 2017_06_05
https://clinicaltrials.gov/archive/NCT01020968/2017_06_05
ClinicalTrials Identifier:
NCT01020968
Updated:
2017_06_05
Heart failure remains a major public health problem, affecting 5 million patients in the US, with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the leading cause of hospitalization in persons over 65 years of age with cost exceeding $29 billion annually. Prognosis is very poor once a patient has been hospitalized with heart failure. The mortality risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at 1 year and well over 50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the need to develop and implement more effective treatments to manage heart failure.
Aastrom is targeting a subset of heart failure patient population, namely those diagnosed with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased diastolic and systolic volume and a low (<40%) ejection fraction (Manolio TA; et al., 1992; Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United States (Richardson P; et al., 1996; Towbin JA; et al., 2006).
This study is a prospective, stratified, randomized, open-label, controlled, multi-center study to assess the safety profile and the efficacy of CRCs administered via catheter in treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group). It will enroll a total of 24 patients at 2 sites in the U.S.
$VCEL could be a "many-digit-multiplier" if Ixmyelocel-T gets accelerated approval by the FDA in the next few weeks, but VCEL won't get the word for 30 days after by written response, and have to wait for the PR and SEC form 8-K disclosure from VCEL
My gut intuition says we get accelerated approval with an another side study, and it will be congrads to the longs
JUST LIKE THIS ONE
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm
VCEL
$VCEL bluesky over $4.55, looking for $7 or better by ER/CC
SEC 13F filed 8-10-2017 showing 2B$ Tute FIRST WASHINGTON CORP acquiring 675K new position in VCEL
Rank 41 out of their 74 positions
https://whalewisdom.com/filer/first-washington-corp#/tabholdings_tab_link
VCEL
Wouldn't this be an 8-K material event? If we received the $6M
http://investors.vcel.com/releasedetail.cfm?ReleaseID=1025740
The funding transfer is subject to approval by the State Administration of Foreign Exchange of the People's Republic of China and is expected to conclude in the third quarter of 2017.
VCEL
$vcel UPGRADES COMING ANYONE ?