The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )
- Thread starter Tug life
- Start date
Good shyt. Welcome to the club.
Reading up on AMRN, the FDA and this ADCOM.
AMRN submitted sNDA w/ the FDA back in March. FDA gave it a PR (Priority Review) Cutting the review time from 10 months to 6 months. While an ADCOM was expected at 1st, the review date was quickly approaching and everyone thought it was to late in the game for an ADCOM. Then boom the FDA dropped the ADCOM (which many investors wanted all along; free advertising basically) would could means theres a problem with the info a company submitted (But in AMRN's case its thought to be due to the extreme broad label it could be used for) and the SP took a HUGE hit.
It should also be noted, The FDA told AMRN not to announce the ADCOM publicly, but AMRN did it anyway. Now FF a few months later, ADCOM is set for 11/14, but the original sNDA date (as of today) of 9/28 still stands. This is leading some to theorize that the FDA plans on granted AMRN an expanded label based to TG levels (150, or more). That label will be BIG. The other side of the coin is, the ADCOM will for AMRN to answer questions (educate the FDA) for an extended label to extended beyond TG level to include all CV risk factors regardless of TG levels (This is due to REDUCE-IT results being so positive, simply lowering TG doesn't really explain it) Now, that will be HUGE. Expanded label to all CV risk factors is why some are thinking this will be the highest selling drug of all time.
And don't for about the EVAP study due to end this month.
Nothing new really, just wrote it up all in one spot.
GLTA
AMRN submitted sNDA w/ the FDA back in March. FDA gave it a PR (Priority Review) Cutting the review time from 10 months to 6 months. While an ADCOM was expected at 1st, the review date was quickly approaching and everyone thought it was to late in the game for an ADCOM. Then boom the FDA dropped the ADCOM (which many investors wanted all along; free advertising basically) would could means theres a problem with the info a company submitted (But in AMRN's case its thought to be due to the extreme broad label it could be used for) and the SP took a HUGE hit.
It should also be noted, The FDA told AMRN not to announce the ADCOM publicly, but AMRN did it anyway. Now FF a few months later, ADCOM is set for 11/14, but the original sNDA date (as of today) of 9/28 still stands. This is leading some to theorize that the FDA plans on granted AMRN an expanded label based to TG levels (150, or more). That label will be BIG. The other side of the coin is, the ADCOM will for AMRN to answer questions (educate the FDA) for an extended label to extended beyond TG level to include all CV risk factors regardless of TG levels (This is due to REDUCE-IT results being so positive, simply lowering TG doesn't really explain it) Now, that will be HUGE. Expanded label to all CV risk factors is why some are thinking this will be the highest selling drug of all time.
And don't for about the EVAP study due to end this month.
Nothing new really, just wrote it up all in one spot.
GLTA
@krazykid18 , @L68
Got this from Ihub, who got it from this guy Luke Timmons who posted it in an SHMP group.
Good evening Shrimpers! This is my first post in this group. I am the co-founder and Chief Operations Officer of Hydrenesis. Though I’m not a shareholder of SHMP, I am directly interested in their success.
First, I just want to mention that we are more than pleased with Peter Letizia and Natural Shrimp’s commitment, and professionalism to the partnership. We are pursuing joint IP opportunities and forging a partnership that will change the way we farm fish.
Over the past several months, Peter has been negotiating a government funded study, guest appearance for our technologies. That was the single most important event that’s happened to date. We tested the Hydrogas technology on several different pathogens and Amoebas. What I have to report shrimpers, is nothing short of amazing.
As this is a private group I would like to share a conversation that I personally had with Dr. Mark Powell, arguably the foremost expert on the Salmon species. His personal opinion, which he will outline in a letter early next week, that I will be happy to share on this group, is that we have a “game changer” in the fight against Amoebic Gill disease.
What does that mean for Natural Shrimp my fellow shrimpers? It means that your patented EC technology, is going to be complimented by our technology in the farming and production of Salmon, and the fight against Amoeba in the transport of farm raised salmon in many countries.
I asked what further testing is needed in this application, and his response was “None Luke, we need to move to the pilot phase and commercialize immediately.” Shrimpers, this is just the tip of the iceberg.
I will have that report available by the middle of next week and will happily share it with this group. Peter already has the numbers worked out for what this means, I’m sure he will share once we provide the necessary releases from the study.
Shrimpers, I hope you realize what we have by the tail here. This is the future.
The bottom line is, stick with Natural Shrimp, F&T, and Hydrenesis. With our combined technology, we are the future of Aquaculture. You won’t be disappointed.
*****EDIT
Googled Dr. Powell he mentioned:
Mark D Powell
Got this from Ihub, who got it from this guy Luke Timmons who posted it in an SHMP group.
Good evening Shrimpers! This is my first post in this group. I am the co-founder and Chief Operations Officer of Hydrenesis. Though I’m not a shareholder of SHMP, I am directly interested in their success.
First, I just want to mention that we are more than pleased with Peter Letizia and Natural Shrimp’s commitment, and professionalism to the partnership. We are pursuing joint IP opportunities and forging a partnership that will change the way we farm fish.
Over the past several months, Peter has been negotiating a government funded study, guest appearance for our technologies. That was the single most important event that’s happened to date. We tested the Hydrogas technology on several different pathogens and Amoebas. What I have to report shrimpers, is nothing short of amazing.
As this is a private group I would like to share a conversation that I personally had with Dr. Mark Powell, arguably the foremost expert on the Salmon species. His personal opinion, which he will outline in a letter early next week, that I will be happy to share on this group, is that we have a “game changer” in the fight against Amoebic Gill disease.
What does that mean for Natural Shrimp my fellow shrimpers? It means that your patented EC technology, is going to be complimented by our technology in the farming and production of Salmon, and the fight against Amoeba in the transport of farm raised salmon in many countries.
I asked what further testing is needed in this application, and his response was “None Luke, we need to move to the pilot phase and commercialize immediately.” Shrimpers, this is just the tip of the iceberg.
I will have that report available by the middle of next week and will happily share it with this group. Peter already has the numbers worked out for what this means, I’m sure he will share once we provide the necessary releases from the study.
Shrimpers, I hope you realize what we have by the tail here. This is the future.
The bottom line is, stick with Natural Shrimp, F&T, and Hydrenesis. With our combined technology, we are the future of Aquaculture. You won’t be disappointed.
*****EDIT
Googled Dr. Powell he mentioned:
Mark D Powell
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Mr. Bruce Leitch, President of NanoPeak Solutions, Inc., said: “We fully appreciate both the challenges and the significant emerging market opportunity of having the ability to deliver CBD in a form that allows for greater absorption and enhanced bioavailability. Multiple scientific studies have indicated that CBD should be processed via nanoemulsion technology in order to be truly water soluble and resulting in consumer products possessing both shelf stability and consistent dosages. NanoPeak has spent significant time reviewing and assessing various nanoemulsification platforms and the Company has great confidence that PBI’s BaroShear K45 System will be instrumental in NanoPeak having the ability to offer the highest quality ingredients to be utilized in CBD products of all types.”
Yahoo is now part of Oath
Yahoo is now part of Oath
Links starting to drop now:
The NLA is recommending icosapent ethyl for atherosclerotic cardiovascular disease (ASCVD) risk reduction in high and very-high-risk patients, 45 years of age or older with clinical ASCVD, or 50 years of age or older with type 2 diabetes requiring medication and with ≥ 1 additional risk factor, and fasting triglycerides of 135-499 mg/dL on maximally tolerated statin, with or without ezetimibe. The NLA recommendation was issued as a Class I, Level B-R (STRONG) recommendation, its highest designation, for icosapent ethyl. The NLA is a leading professional society dedicated to enhancing the practice of lipid management in clinical medicine.
Yahoo is now part of Oath
Edit***
AHA on twitter saying Late Breaking News will be dropping early this week. Some thinks its AMRN related cause the EVAP study ended on the 1st.
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