The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )

[KING WILL]

I argued previously that $350 million was a too conservative number and while the increased guidance is very bullish, it still seems conservative considering the year-to-date growth trends. The low end which suggests very modest sequential net sales growth compared to the second quarter sales of $97-101 million. Based on the current prescription growth trends, I believe Amarin is on track to generate full-year net sales at least at the high end of the company’s guidance range, and possibly, significantly above it, especially if Vascepa’s label is expanded in late September.

https://seekingalpha.com/article/4273355-amarins-updated-guidance-may-still-prove-conservative

sNDA in Sept.

EVAPORATE results due in Sept.

In this study, EPA is being described as a luqiud stent.

Not only does it decrease plaque in the Artieries, it increases the size of the Lumen.

But to piggy back on those numbers again.

I think $380M-$420M is to low of an estimate too. Assuming 20% increase each Q puts us at about $435M.

Sales jumped by about 50% in the 4th Q last year when the REDUCE-IT results were announced.

 

[Starski]

If y’all break that 9.50 range resistance ( close over it) it’s of to the races for crmd very bullish

If it dips and holds the upper 8.00’s it’s a quick buy and flip for me imo.

 

[KING WILL]

Roller Coaster for AMRN today.

Opens Red, goes Green, breaks ATH, gets up over 4%, only to fall, almost hit Red again, only to close up 1.31%.

Cant complain tho, no pull back (for 2 trading days) after a 16% day.

 

[Starski]

Roller Coaster for AMRN today.

Opens Red, goes Green, breaks ATH, gets up over 4%, only to fall, almost hit Red again, only to close up 1.31%.

Cant complain tho, no pull back (for 2 trading days) after a 16% day.

Think they will be a reversal next week imo

 

[KING WILL]

possible.

cant go up 4ever.

 

[KING WILL]

The buildup of amyloids in the brain is similar to the buildup of plaque in the blood vessels: they inhibit bodily functions.

“We can get buildup of clustural plaques in the arteries that help block the blood flow,” Carlsson said. “We can also have a buildup of a protein
called amyloid in the plaques in the brain tissue itself. There are a couple of different plaques that can negatively affect our brain health. In the
study, we are actually looking at both of those kinds, the blood vessel build-up of plaques and also the brain tissue that amyloids cluster in.”

During the past few decades, fish oil has gained prominence in its impact on heart health, spurred by the documented long lives of Japanese
fishermen. Carlsson and WI ADRC want to see if fish oil can have an impact of Alzheimer’s disease in veterans.

“There are some beneficial effects that fish oil has,” Carlsson said. “Somehow, it tends to improve blood vessel function. It helps to reduce
inflammation. There are a lot of beneficial effects of fish oil




The Capital City Hues/04/22/19/Researching impact of fish oil

This BRAVE study will be HUGE.

 

[Tug life]

Think they will be a reversal next week imo

Maybe some profit taking and short covering, but AMRN has no reason fundamentally for a trend reversal. They just released that heart pill sales are booming, and their revenue stream will benefit heavily. Not to mention earnings report coming at the end of the month and FDA news this summer.

Any pullback and dips that will happen will more than likely be temporary unless bad news of some kind hits

 

[KING WILL]

With guidance already raised, do you think positive ER results are already priced in?

 

[Starski]

Maybe some profit taking and short covering, but AMRN has no reason fundamentally for a trend reversal. They just released that heart pill sales are booming, and their revenue stream will benefit heavily. Not to mention earnings report coming at the end of the month and FDA news this summer.

Any pullback and dips that will happen will more than likely be temporary unless bad news of some kind hits

I’m saying pullback to low 20’s upper 19.00’s

 

[KING WILL]

Plan on More Pharma Megamergers

 

[Tug life]

CRMD RECEIVES FDA UPDATE

Yahoo is now part of Oath

In its feedback, the FDA did not raise any additional questions regarding the analyses provided and indicated that it would conduct a thorough review of all of the clinical data when the clinical study report is submitted for LOCK-IT-100. In FDA’s response to the Company’s question on whether LOCK-IT-100 is adequate as a single study to support a New Drug Application (NDA), the FDA stated that while the data from LOCK-IT-100 and supporting information may be sufficient, it cannot confirm that the data from LOCK-IT-100 are adequate to support an indication for prevention of CRBSI in hemodialysis patients until it has completed its review of the NDA. The Company will continue discussions with the FDA concerning the chemistry, manufacturing and controls (CMC) data that will be needed to support Neutrolin’s NDA. FDA’s feedback on the CMC data is an important regulatory requirement prior to the Company requesting a pre-NDA meeting.

What this means to me is that even though this is good news, people want the home run news so it'll probably sell off like we did last couple of months. I'm contemplating on selling some high and buying back in on the low side.

 

[Tug life]

Based on the FDA’s feedback, the Company believes it has completed Phase 3 of clinical development for Neutrolin in hemodialysis patients and does not need to conduct another clinical trial at this time.

After dissecting all the info that has been put out, it seems as though CRMD has been given the go ahead to file for NDA and a second phase 3 trail is not likely to happen, so that eliminates that risk. Although they were very vague in their language in the press releases. It seems as though they are being very careful with what they say. They can't speak for the FDA and say that we absolutely don't need another trail, and our NDA will be approved with absolute certainty before the FDA says that themselves. But if you can read between the lines you'll see that everything they have planned for is going very well according to plan. I just wish the PR wasn't so vague andvwe saw better price action because of it

 

[Tug life]

This post from Yahoo finance perfectly sums up our current situation. I believe more and more that approval is immanent. I'll be looking to add significantly to my position

The most important part of today's PR is " Based on the FDA’s feedback, the Company believes it has completed Phase 3 of clinical development for Neutrolin in hemodialysis patients and does not need to conduct another clinical trial at this time." PERIOD!
As someone who works in BF and has sat on teams to discuss several NDA filings, the FDA is NEVER going to flat out say "yes, it is ok to submit the NDA". If the NDA or the data is not sufficient, the FDA will Refuse to File or simply not approve the product. This comment from the PR " the FDA stated that while the data from LOCK-IT-100 and supporting information may be sufficient, it cannot confirm that the data from LOCK-IT-100 are adequate to support an indication for prevention of CRBSI in hemodialysis patients until it has completed its review of the NDA" is standard language as the FDA is in no position to comment without reviewing the NDA.

The point is that they're going to file the NDA HAVING DONE ONE P3 TRIAL. Of course the FDA won't make a determination until they review the NDA. That's the whole point of the NDA! The main point and great news here is that it looks like an NDA will be filed without another P3. This is the best news since the trial was stopped last year. This should fly today despite the naysayers here and elsewhere.

 

[newarkhiphop]

CRMD RECEIVES FDA UPDATE

Yahoo is now part of Oath



What this means to me is that even though this is good news, people want the home run news so it'll probably sell off like we did last couple of months. I'm contemplating on selling some high and buying back in on the low side.

I have to learn to be patient with this stock stuff, after reading your post yesterday sold half my shares since we were up lol, looks like today gonna be a good day

 

[ORDER_66]

I haven't sold any of my CRMD... shyt goes up like everyday...