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4 business days, google it, I believe ..... and just broke the 6.20 wall again, hitting 6.30's
I am going to have to call them and see if their lab on processing on Saturdays
Its simple, the FDA IXCELL meeting was to occur in the 3rd quarter and VCEL would be given a written response from FDA after 30 Days,
per the CC on 2nd quarter
Maybe word leaked out to the tutes, who knows
I only said what was in the most recent press release, and it states, so what the ceo talks about we will have to wait and see.
Mr. Colangelo will also participate in the plenary session "Implications of Commercialization: What Does Approval Mean?" at 9:15am PDT.
VCEL
$7's before next Weds 9.15 am panel conference
That is why positive FDA News on accelerated approval of Ixmyelocel-T on a 32.8M O/S is going to be incredibly explosive
Come $6.50 close today, would that be asking too much ?
72K on the bid at 5.75, could test the $6's today
My gut tells me there is a 1M short in the $6.00 to $6.60 range, when the ph2b results came out in March couple years ago
I lean to bluesky over $6.60
Looking great, I am so excited, as you and I have been here a long long long time and its REALLY all coming together now.
Did you see it yet?
New VCEL "Job GROWTH" position on VCEL page, tells me IXCELL is getting approved soon, and VCEL MGMT knows it and is preparing already for it
http://vcel.com/careers/
VCEL
How do I sit on my hands for 5 years or more, need help to protect me from me. LOL
Here are those long term hold charts, OMG if VCEL can do this, had the charts set on MAX but I see it reverts back to 1 yr chart, change the setting to max
https://finance.yahoo.com/chart/AMGN#eyJpbnRlcnZhbCI6Im1vbnRoIiwicGVyaW9kaWNpdHkiOjEsImNhbmRsZVdpZHRoIjo0LjA3MDM1MTc1ODc5Mzk2OTUsInZvbHVtZVVuZGVybGF5Ijp0cnVlLCJjcm9zc2hhaXIiOnRydWUsImNoYXJ0VHlwZSI6ImxpbmUiLCJleHRlbmRlZCI6ZmFsc2UsImNoYXJ0U2NhbGUiOiJsaW5lYXIiLCJzdHVkaWVzIjp7InZvbCB1bmRyIjp7InR5cGUiOiJ2b2wgdW5kciIsImlucHV0cyI6eyJpZCI6InZvbCB1bmRyIiwiZGlzcGxheSI6InZvbCB1bmRyIn0sIm91dHB1dHMiOnsiVXAgVm9sdW1lIjoiIzAwYjA2MSIsIkRvd24gVm9sdW1lIjoiI0ZGMzAzMSJ9LCJwYW5lbCI6ImNoYXJ0IiwicGFyYW1ldGVycyI6eyJoZWlnaHRQZXJjZW50YWdlIjowLjI1LCJ3aWR0aEZhY3RvciI6MC40NSwiY2hhcnROYW1lIjoiY2hhcnQifX19LCJwYW5lbHMiOnsiY2hhcnQiOnsicGVyY2VudCI6MSwiZGlzcGxheSI6IkFNR04iLCJjaGFydE5hbWUiOiJjaGFydCIsInRvcCI6MH19LCJsaW5lV2lkdGgiOjIsInN0cmlwZWRCYWNrZ3JvdWQiOnRydWUsImV2ZW50cyI6dHJ1ZSwic2V0U3BhbiI6eyJiYXNlIjoiYWxsIiwibXVsdGlwbGllciI6MX0sImN1c3RvbVJhbmdlIjpudWxsLCJzeW1ib2xzIjpbeyJzeW1ib2wiOiJBTUdOIiwic3ltYm9sT2JqZWN0Ijp7InN5bWJvbCI6IkFNR04ifSwicGVyaW9kaWNpdHkiOjEsImludGVydmFsIjoibW9udGgiLCJzZXRTcGFuIjp7ImJhc2UiOiJhbGwiLCJtdWx0aXBsaWVyIjoxfX1dfQ%3D%3D
https://finance.yahoo.com/chart/BIIB?ltr=1#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
https://finance.yahoo.com/chart/REGN?ltr=1#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
Yes, and I believe accelerated approval is a shoe in. I can't wait for the formal announcement.
I think ceo Nick already knows.
The next ER/CC is going to be awesome if profitable on that one, since R&D expenses are downsizing
I am expecting profitable.
I think the whole investment world will be watching this
“Implications of Commercialization: What Does Approval Mean?” at 9:15am PDT.
VCEL NEWS Mr. Colangelo will also participate in the plenary session “Implications of Commercialization: What Does Approval Mean?” at 9:15am PDT.
http://ih.advfn.com/p.php?pid=nmona&article=75735790&symbol=VCEL
VCEL
When did this page come out http://investors.vcel.com/index.cfm
Question, what would you rather have a stem cell treatment for, your knee, or your heart, if you were in dier need, (sp)
Ixmyelocel-T has been in development since 1996 or so, takes time to get to market.
Do we have a new page on the VCEL site http://investors.vcel.com/index.cfm
We know or anticipate Q4 to be the knockout, but Q3 might be just a little bit profitable. with a dash of IXCELL
Q4 or Q3
Ixmyelocel-T upon commercialization can do 3000 procedures which will be probably a dollar or two a share profitability
Until it expands, the Ann Arbor facility.
They are already set up to run. Need proof?
MACI alone is going to bring profitability to VCEL, Ixcell Is icing on the cake.
Let's see the shorters bitch on FDA news on the .05 rule as we blow through the double digits up to $30 land
There is more than enough safety data, you know it's coming.
The only ones I see bitching about the .05 rule is the shorters
Turn the question around and ask "Would a comment about VCEL type B meeting from the FDA require a filing of some sort, do you know ?
In that case I say yes, VCEL has 4 business days to 8-K it as a material event.
But as to your question, The ceo did comment on the last conference call that "a confirmed meeting was scheduled with the FDA" and we saw no filing on that.
If anyone else has any ideas, add to the thoughts please.
Unconfirmed, just assuming meeting is done since ceo signed up for next Tuesday conference, guessing he wouldn't go there empty handed.
That is going to be an answer we will all be watching live on webcast to find out, at least I won't miss it.
lasers, How long does VCEL have to be over $5.00 for the $5 Tutes to jump in ?
Is there any general rule of thumb on this topic ?
Hopeing part of the overview being presented to the Investment Community will be about Ixmyelocel-T and the Recent FDA meeting
And the progress of MACI
Nice news this morning
Tell me that when VCEL gets accelerated approval in 30 to 40 days from the FDA, tell me who the front runner is, not who is wallstreets bad better is
Yes, 20K procedures is the potential market for MACI, which at $43K, brings in $860M
That is Vericel running MACI at on all 8 cylinders
Not sure what that does to share price, but would be up in nosebleed land, high double digits
Now bring in Ixmyelocel_T, and we have another $AMGN at hand, right?
BTW, tougher getting a job at vcel now, only 6 positions available
300 MACI procedures covers the nut possibly
Thanks, Nick. Total GAAP net revenues for the quarter ended June 30, 2017 were approximately $17 million and included approximately $12.9 million of MACI and Carticel net revenues and approximately $4.1 million of Epicel
12.9M divided by $43k per procedures is 300
Research and development expenses for the quarter were $3 million
Loss from operations for the quarter ended June 30th, 2017 were $2.5 million
If you remove the R&D expenses, VCEL is already profitable.
Sooner than later R&D is going to end, once the R&D expenses end from 2b crossover study, VCEL will be profitable on $12.9M gross MACI sales, plus the ongoing Epicel sales that was recorded.
This 3rd quarter aren't we expecting between 400 and 600 MACI procedures?
https://seekingalpha.com/article/4096867-vericels-vcel-ceo-nick-colangelo-q2-2017-results-earnings-call-transcript?part=single
VCEL
lasers, can you clearify to pbor in post 6468 what you meant
on profit
post 6468 by pbor, The only thing I don't understand is that although MACI is a very unique solution, why is it sold at such discount price. (I remember lasers mentioned there is $1000 net profit on MACI per procedure)
Other companies sell orphan drug for up to hundreds of thousands.
I'm not arguing that the price of the product should be higher, and just trying to understand how do they come up with prices.
*************************************************
From the recent CC,
Gross profit for the quarter ended June 30, 2017 was $9.3 million or 55% of net revenues compared to $5.5 million or 43% of net product revenues for the second quarter of 2016. Excluding the impact of the $1.4 million partial reversal of the reserve, gross margins were 51% for the second quarter.
************************************************
IMHO, when a company has operating expenses, it takes a certain number of procedures to do just to breakeven or cover the nut.
After that, any procedures over and above the minimum floor are
gravy (profit over and above cost of goods sold). The profit margin on 300 Maci procedures is not the same profit margin on 20K Maci procedures once the company does enough procedures to cover the nut. Therefore you can not assign a $1000
profit per Maci procedure as a blanket number across the board.
pbor, I don't have all the answers, but what makes Vericel so unigue is all their treatments are autologous, meaning from your body to your own body, no rejection, Epicel, MACI, Ixmyelocel-T
There is no generic
There currently is no FDA cure for heart DCM
There is no immediate competition, IMHO, that is why we got RMAT
This is stem cell, from you, to you treatment
https://www.google.com/search?source=hp&q=autologous+&oq=autologous+&gs_l=psy-ab.3..0l4.2405.2405.0.5323.1.1.0.0.0.0.92.92.1.1.0.foo%2Cnso-ehuqi%3D1%2Cnso-ehuui%3D1%2Cewh%3D0%2Cnso-mplt%3D2%2Cnso-enksa%3D0%2Cnso-enfk%3D1%2Cnso-usnt%3D1%2Cnso-qnt-npqp%3D0-1633%2Cnso-qnt-npdq%3D0-5608%2Cnso-qnt-npt%3D0-1229%2Cnso-qnt-ndc%3D2051%2Ccspa-dspm-nm-mnp%3D0-06145%2Ccspa-dspm-nm-mxp%3D0-153625%2Cnso-unt-npqp%3D0-1506%2Cnso-unt-npdq%3D0-4694%2Cnso-unt-npt%3D0-061%2Cnso-unt-ndc%3D300%2Ccspa-uipm-nm-mnp%3D0-007625%2Ccspa-uipm-nm-mxp%3D0-053375%2Ccfro%3D1...0...1.1.64.psy-ab..0.1.90....0.nEFWvmXJ8lg
au·tol·o·gous
/ô'täl?g?s/
adjective
adjective: autologous
(of cells or tissues) obtained from the same individual.
"autologous bone marrow transplants"
VCEL
Very informational, so you are saying accelerated approval Vcel can start commercialization and billing, without BLA ?
I know we are set up for initial launch of 3000 capable
I know cpt codes have to get established, right?
I don't know how ceo Nick can sleep at night let alone the rest of the VCEL mgmt., 0
Thanks lasers
pbor, quick question, how can you make a generic Ixmyelocel-T
Maybe I don't understand the context you are asking lasers a question.
Thinking each Ixcell treatment is DNA fingerprinted per say from the very person it is treating
lasers, help me think this out, please
Is the BLA still 12 months under RMAT or 6 months, I thought I read somewhere 6 months, or maybe I am getting this mixed up with something else.
And def agree on the feedback data you mentioned.
That is exactly why I think we will get accelerated approval.
The data is there.
We don't know the date of the FDA meeting other than they stated in the recent conference call that it is scheduled for the end of this quarter. September 30, 2017
https://finance.yahoo.com/news/edited-transcript-vcel-earnings-conference-151228320.html
Then, from the date of that meeting, the FDA will issue VCEL a written response in 30 days.
Then, imho, VCEL has to 8-K it as a material event within 4 business days, gives them time to set up conference call for investors, just like the Dec 14th, 2016 PDUFA FDA decision and CC
that occurred with MACI
Which in that CC call on MACI ceo Nick stated VCEL will be the very first profitable stem cell company in 2017 Q3 or Q4
http://edge.media-server.com/m/p/c6n8umpi
CC call can be found in the ibox under "Conference Calls"
VCEL