The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )
- Thread starter Tug life
- Start date
Tug life
I stay fly like a guillemot
Nice read on both Amarin and Acasti pharma Acasti Pharma And Amarin In Severe Hypertriglyceridemia - Acasti Pharma Inc. (NASDAQ:ACST) | Seeking Alpha they both will be realising data in the next 2 months both of which is expected to be really good. I'm loading up on Acasti in the $2 range and Amarin in the $15 range I still hold firm to my beliefs that Acasti, Amarin and Cormedix is the holy trinity in the biotech sector from November to January.
Cormedix recently released that they have had constructive talks with the FDA regarding the CMC portion of the NDA. CMC stands for chemicals manufacturing and controls. This is basically about how cormedix will maintain the quality of Neutrolin the as it was in the study. Cormedix already distributes Neutrolin in Europe so they understand how to replicate the formula very well. This was a very important part of the NDA and probably the largest so since they got that out of the way the rest should be relatively smooth.
Next catalyst is pre NDA meeting which is very important and very huge.
One last thing to note is our largest shareholder Elliott associates LLP and Elliott management. If you don't know about them they are the biggest activist hedge fund in the world and that is also perhaps the most powerful. They takeover public companies force the board members out bring in better ones and get warrants and preferred stock. They then help the stock price appreciate and ultimately force the company into a merger or sell the company for a profit. They have a business model of always making a profit and being as tough as nails.
Cormedix is the only biotech company Elliott owns. They just started an activist campaign on At&t, they don't take much risk and with their track record I'm pretty confident that they will get the most out of this company. If this does become the standard of care, Elliott will not sell for anything less than 2 billion. If you are not familiar with Paul singer and Elliott management watch this video you will see how powerful this man and his company is.
Cormedix recently released that they have had constructive talks with the FDA regarding the CMC portion of the NDA. CMC stands for chemicals manufacturing and controls. This is basically about how cormedix will maintain the quality of Neutrolin the as it was in the study. Cormedix already distributes Neutrolin in Europe so they understand how to replicate the formula very well. This was a very important part of the NDA and probably the largest so since they got that out of the way the rest should be relatively smooth.
Next catalyst is pre NDA meeting which is very important and very huge.
the next news from the FDA will be very important, if we hit all those markers it's basically a signal we're getting approved.
One last thing to note is our largest shareholder Elliott associates LLP and Elliott management. If you don't know about them they are the biggest activist hedge fund in the world and that is also perhaps the most powerful. They takeover public companies force the board members out bring in better ones and get warrants and preferred stock. They then help the stock price appreciate and ultimately force the company into a merger or sell the company for a profit. They have a business model of always making a profit and being as tough as nails.
Cormedix is the only biotech company Elliott owns. They just started an activist campaign on At&t, they don't take much risk and with their track record I'm pretty confident that they will get the most out of this company. If this does become the standard of care, Elliott will not sell for anything less than 2 billion. If you are not familiar with Paul singer and Elliott management watch this video you will see how powerful this man and his company is.
To Food and Drug Administration,
1990
OCT 22’19 ml0i2A
I am currently Deputy Secretary of Health State of New Mexico and Associate Professor of Medicine
Division of Cardiology, University of New Mexico. Prevention of atherosclerotic cardiovascular disease is
paramount for the Nation's health.
As a cardiologist with a very busy clinical practice, I have been thoroughly impressed by the clinical
outcomes ofthe REDUCE-IT trial. Many of my colleagues and I did not suspect that Vascepa, or
icosapent ethyl, would work, especially since so many omega-3 fatty acid trials have failed.
I was thrilled by the data I saw at the American Heart Association Scientific Sessions last November. It
has also been impressive to witness how strongly the data has been adopted into practice guidelines
and scientific statements over the last year. Clinician societies including American Diabetes Association,
European Society of Cardiology/European Atherosclerosis Society, National Lipid Association, American
Heart Association have all incorporated the REDUCE-IT findings into their guidelines or scientific
documents. I look to these organizations to help guide my practice and the consistency has been
extremely encouraging.
I hope that the FDA will recognize the importance ofthis therapy to cardiology and will approve the
expanded indication as soon as possible so that we can continue to use it in patients who need it the
most.
Thank you.
Abinash Achrekar MD MPH
Deputy Secretary of Health
State of New Mexico
Associate Professor of Medicine
University of New Mexico
1990
OCT 22’19 ml0i2A
I am currently Deputy Secretary of Health State of New Mexico and Associate Professor of Medicine
Division of Cardiology, University of New Mexico. Prevention of atherosclerotic cardiovascular disease is
paramount for the Nation's health.
As a cardiologist with a very busy clinical practice, I have been thoroughly impressed by the clinical
outcomes ofthe REDUCE-IT trial. Many of my colleagues and I did not suspect that Vascepa, or
icosapent ethyl, would work, especially since so many omega-3 fatty acid trials have failed.
I was thrilled by the data I saw at the American Heart Association Scientific Sessions last November. It
has also been impressive to witness how strongly the data has been adopted into practice guidelines
and scientific statements over the last year. Clinician societies including American Diabetes Association,
European Society of Cardiology/European Atherosclerosis Society, National Lipid Association, American
Heart Association have all incorporated the REDUCE-IT findings into their guidelines or scientific
documents. I look to these organizations to help guide my practice and the consistency has been
extremely encouraging.
I hope that the FDA will recognize the importance ofthis therapy to cardiology and will approve the
expanded indication as soon as possible so that we can continue to use it in patients who need it the
most.
Thank you.
Abinash Achrekar MD MPH
Deputy Secretary of Health
State of New Mexico
Associate Professor of Medicine
University of New Mexico
Tug life
I stay fly like a guillemot
Good video on Acasti and Amarin. They break it down real well for those who aren't familiar.
A lot of these letters being sent out to the FDA ahead of the ADCOM. Hopefully it helps.
AMRN won a court battle vs generics yesterday, or the day before. Also, JT added more shares.
Good news coming in before the ADCOM.
I've been looking into longing this stock, they have earnings Nov 7 which they're expected to beat. But it looks like the real bubble could happen Dec 28th when they go before the PDUFA.
I'll wait a little more before buying up some, could be a nice new years gift.
I'll wait a little more before buying up some, could be a nice new years gift.
which stock are u talking about? crmd?
Def gonna beat Earnings, and this is after they raised guidance earlier this year.
I never post them here, but every Friday the Weekly Scripts are posted on a few different sites I visit. Bro, every week they are posting either ATH and top 3 ATH.
ADCOM is 11/14, or 11/15 I cant remember right now.
Then yea, PDUFA date is 12/28.
The last 2 months of 2019 could end crazy for AMRN.
****EDIT
ER is in the 5th.
Last edited:
Numbers are out for the week:
ATH across the board for Total, New and Refill Rx.
ATH across the board for total market too, in the categories listed above.
Total market share at 54.50%. I remember when that shyt was in the 40's. V is coming a LONG way.
ATH across the board for Total, New and Refill Rx.
ATH across the board for total market too, in the categories listed above.
Total market share at 54.50%. I remember when that shyt was in the 40's. V is coming a LONG way.
Not sure if I posted this before, but this is a really good read on Humira. The process to make and protect Humira is very similar to Vascepa.
Protect at All Costs: How the Maker of the World’s Bestselling Drug Keeps Prices Sky-High
Humira is currently the #1 selling drug in the world with $18B in sales. This is huge, because V has a MUCH bigger treatable population than Humira(if ADCOM goes as planned).
Below is a comment made when I posted this link on YMB:
It’s all going to depend on the label, but right now if we assume it’s 135+tg’s then the V marketable population will be as much as triple humira.
Now if it’s no tg’s then it gets really nuts, nearly 7x humira.
Considering humira is $18b this year it’s liter insane to think what V could be. That’s why when anyone starts talking about trillion market cap it’s not a stretch. Not even a little. Of course I believe BP takeout occurs way sooner but it really is only comparable to aspirin.
Vascepa one day becoming the best selling drug of all time isnt that far fetched at all.
Protect at All Costs: How the Maker of the World’s Bestselling Drug Keeps Prices Sky-High
Humira is currently the #1 selling drug in the world with $18B in sales. This is huge, because V has a MUCH bigger treatable population than Humira(if ADCOM goes as planned).
Below is a comment made when I posted this link on YMB:
It’s all going to depend on the label, but right now if we assume it’s 135+tg’s then the V marketable population will be as much as triple humira.
Now if it’s no tg’s then it gets really nuts, nearly 7x humira.
Considering humira is $18b this year it’s liter insane to think what V could be. That’s why when anyone starts talking about trillion market cap it’s not a stretch. Not even a little. Of course I believe BP takeout occurs way sooner but it really is only comparable to aspirin.
Vascepa one day becoming the best selling drug of all time isnt that far fetched at all.
11/5=Q3 earnings
11/12. Briefing docs
11/14 adcom
11/16 aha- independent cost effectiveness By Weintraub
11/17 aha- Icosapent ethyl presentation on other uses (Alzheimer’s?)
11/18 aha Evaporate
Late November Canada
Early December (likely before 12/28) Pdufa- new label
Depends on how much info is released 11/18 could be huge.
Appreciate the rundown, I'll play earnings and pick up some 2020 contracts in the dip after before the end of the month.
Looking at the chain the week of Jan 13 has the most interest, it seems most people have penciled this happening late December and skyrocketing when markets are back up. $35 has the most volume.
SAN DIEGO, Nov. 1, 2019 /PRNewswire/ -- Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP) announced today new data demonstrating that suppression of NR2F6 using patent-pending compounds developed by the Company results in selective inhibition of new blood vessels under conditions associated with cancer and wet macular degeneration. The data, which was obtained using human umbilical vein endothelial cells (HUVEC), indicates that NR2F6 may have a larger biological role than originally suspected.' data-reactid="12">SAN DIEGO, Nov. 1, 2019 /PRNewswire/ -- Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP) announced today new data demonstrating that suppression of NR2F6 using patent-pending compounds developed by the Company results in selective inhibition of new blood vessels under conditions associated with cancer and wet macular degeneration. The data, which was obtained using human umbilical vein endothelial cells (HUVEC), indicates that NR2F6 may have a larger biological role than originally suspected.
Regen BioPharma, Inc. has been utilizing NR2F6 as a target for immune modulation and cancer stem cells. To the Company's knowledge, this is the first indication to date that NR2F6 is involved in the formation of new blood vessels.
Thomas Ichim, PhD, co-inventor of the patent and consultant to the Company. "In our experiments, we observed that inhibition of NR2F6 selectively blocked multiplication of blood vessel cells that were stimulated with Vascular Endothelial Growth Factor (VEGF). Since VEGF is associated with disease conditions, it is possible that our approach possesses some degree of specificity in blocking pathological but not healthy formation of new blood vessels. New blood vessels suggests that this approach may not suppress healthy blood vessels which are primarily formed independently of VEGF."' data-reactid="14">"New blood vessels are typically not formed in an adult except in conditions such as cancer (in which the tumor cells require a new blood supply) or in wet macular degeneration; a condition in which new blood vessels result in impairment of vision," said Thomas Ichim, PhD, co-inventor of the patent and consultant to the Company. "In our experiments, we observed that inhibition of NR2F6 selectively blocked multiplication of blood vessel cells that were stimulated with Vascular Endothelial Growth Factor (VEGF). Since VEGF is associated with disease conditions, it is possible that our approach possesses some degree of specificity in blocking pathological but not healthy formation of new blood vessels. New blood vessels suggests that this approach may not suppress healthy blood vessels which are primarily formed independently of VEGF."
$2.8 Billion in 20181) for cancer and Lucentis (Sales $1.9 Billion in 20182).' data-reactid="15">Drugs which target VEGF as a means of suppressing pathological blood vessel formation include Avastin (Sales $2.8 Billion in 20181) for cancer and Lucentis (Sales $1.9 Billion in 20182).
David Koos. "We believe this coupled with our current small molecule therapies as a quality additional approach to treating cancer."" data-reactid="16">"What this data demonstrates is a potential mechanism to kill cancer cells without the toxicity associated with conventional treatments," noted the Company's Chairman & CEO David Koos. "We believe this coupled with our current small molecule therapies as a quality additional approach to treating cancer."
Yahoo is now part of Verizon Media
Regen BioPharma, Inc. has been utilizing NR2F6 as a target for immune modulation and cancer stem cells. To the Company's knowledge, this is the first indication to date that NR2F6 is involved in the formation of new blood vessels.
Thomas Ichim, PhD, co-inventor of the patent and consultant to the Company. "In our experiments, we observed that inhibition of NR2F6 selectively blocked multiplication of blood vessel cells that were stimulated with Vascular Endothelial Growth Factor (VEGF). Since VEGF is associated with disease conditions, it is possible that our approach possesses some degree of specificity in blocking pathological but not healthy formation of new blood vessels. New blood vessels suggests that this approach may not suppress healthy blood vessels which are primarily formed independently of VEGF."' data-reactid="14">"New blood vessels are typically not formed in an adult except in conditions such as cancer (in which the tumor cells require a new blood supply) or in wet macular degeneration; a condition in which new blood vessels result in impairment of vision," said Thomas Ichim, PhD, co-inventor of the patent and consultant to the Company. "In our experiments, we observed that inhibition of NR2F6 selectively blocked multiplication of blood vessel cells that were stimulated with Vascular Endothelial Growth Factor (VEGF). Since VEGF is associated with disease conditions, it is possible that our approach possesses some degree of specificity in blocking pathological but not healthy formation of new blood vessels. New blood vessels suggests that this approach may not suppress healthy blood vessels which are primarily formed independently of VEGF."
$2.8 Billion in 20181) for cancer and Lucentis (Sales $1.9 Billion in 20182).' data-reactid="15">Drugs which target VEGF as a means of suppressing pathological blood vessel formation include Avastin (Sales $2.8 Billion in 20181) for cancer and Lucentis (Sales $1.9 Billion in 20182).
David Koos. "We believe this coupled with our current small molecule therapies as a quality additional approach to treating cancer."" data-reactid="16">"What this data demonstrates is a potential mechanism to kill cancer cells without the toxicity associated with conventional treatments," noted the Company's Chairman & CEO David Koos. "We believe this coupled with our current small molecule therapies as a quality additional approach to treating cancer."
Yahoo is now part of Verizon Media