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I hope these are JT’s and Kennedy’s ace-in-the-hole!!!!!
1000% agree BB, JT can NOT approach this like JZ. At least give the 60 notice to the FDA saying the Anchor CRL request have been met with the completion of the positive R-IT. Amarin is moving forward
Do we know the DMC physician were who reviewed R-IT?
Good morning! Has anyone thought more about the FOIA request that included Nissen. Is it possible he was lobbying Janet to push out the PDUFA Amarin until the his trial was completed to confirm the CV benefits (yes I know the 2 drugs are completely different!)
There is more to this FOIA than we are being told
Yep, me too!
Yep!! I think JT will be better prepared than JZ
100% agree
I just listened to the call. JT was obviously pissed. Im glad he put the FDA on notice in the first minute, not going to play by Janet’s rules. FDA asking JT to hold this information sounds borderline criminal.
The last question from Roth Capital IMO was the best. They know Amarin has been prepared for the Adcom. JT knows this is going to be a fight and Will have his team ready. The Bhatt-man will be the closer!!!
Maybe JT wants to shop around?????????
Any ideas of the total share count after today’s secondary? It was 330.69 million in float (Ameritrade) with total of 386 million (including RSU and options- SA article).
So 350 million ish shares now in float?
No, its new. Posted on the FDA site 7/17/2019. Basically TRASH. Wants a CRL, a new study and cancel the Evaporate study. SMH.
My guess is he will continue to post these frivolous CP’s until September.
Team, here is the 4th one. IMO he has to be working for the supplements and OTC products.
https://www.regulations.gov/document?D=FDA-2019-P-3424-0001
MRC, I can say with almost 20 years in Medical Device sales this is a false statement. With my past company we co-marketed an osteoporosis drug for post spinal fracture treatment. With that said, I have a bit of experience with both pharma, tissue and med device. I assure you that the FDA regulates drugs tissue and devices far more than they would care about a supplement.
Good luck with that thought.
Bunker talk!! ??????????
Thx Sam, I saw the same thing. IMO JT is still playing it super conservative, and I am fine with it. Glad he is moving forward expanding the sales force and not making the same mistakes as JZ did years ago.
Its not the true 5g but the ATT so called update on my iphone. Its definitely quicker
Jenga, Jenga, Jenga!!! ????????
Tasty, By Christmas time I will be ready to party with you and the reindeer!!!
All Noise, they are at 8-12 years out.
G, Saw that too. This board is GREAT!!!!!!!
I would like to hear opinions on the following:
For me the multi-billion dollar question now is does the ACC adopt the same stance moving forward as the ADA did before the sDNA is approved?
If that were to happen, how do you truly value the company? $25 - 50 billion (very conservative numbers based on the market now) or GIA and partner different markets to maximize the value over time like some have suggested.
Will the FDA fast track the approval as did the Canadians?
Any thoughts on what will be ‘on label’ ?
Thx Team!!!
Great point, I wonder now if we do get fast tracked now? Adcom now going to be more of ‘what will be on-label’ and less about MO. ??
I agree Marzan, the STAT call will be a 'hit job' by AF and Herper to drive the stock price down. I think people are kidding themselves to think this call will be positive.
Thx Mike. Herper and HF will do anything possible to make AMRN their first example. I dont trust anything that comes out of their mouths. It will be interesting to see who their ‘expert’ will be during this event
Its funny to read ‘expert research benefit investors by giving them timely access to UNBIASED real world perspectives’. LOL, is this a joke?????
My hope is that the new data is so over whelming that it will make them look foolish if they take a negative tone.
100% agree. The question I responded to was from Sharinky.
Pretty easy decision for me, include the ANCHOR patient population liked they said they would after the last adcom.
Not a bad qtr, JT wont say anything ground shaking today on the CC. I actually like the conservative tone.
I think BioB is right, JT is going to save the ground shaking info for the ACC presentations March 18th. This would be a great time to announce the submission of the sNDA!
In short, No. IMO, its only a matter of time before someone starts the bidding war for the company.
Novarits Question: Does V fit for them?
With Fluvastatin - lescol and Canakinumab already in their bag, IMO it looks like V would complete their CV risk reduction offerings??? Meaning they would have the total package for a prescribing physician??? What am I missing?
Good Point BB.
'I think it's a plausible theory Amarin will NOT submit sNDA UNTIL the FDA is fully prepared to protect against DS falsely advertising and use of Omega 3 "supplements" that contain synthetically modified processing.'
My thought is to submit the sNDA ASAP and FORCE the FDA to address it NOW. IMO, this would also force the hand of the Judge in the ITC case.
Thank you to everyone on this board. What an awesome group of investors!!! Great 90 minute CC on last night!!!! Doctors Miller and Bush were very impressive. BB and others on this board have touched on the T2DM market before but the CC really opened my eyes to the size of this market!!! Dr. Bush named 2 of the 3 drugs below with their CV benefits 13-14% RRR. Below is a quick search of the size of this market. see below:
Trulicity 13%
Eli Lilly's Trulicity is projected to be the No. 1 top-selling diabetes drug in the world by 2024. EvaluatePharma thinks the drug will rake in annual sales of $4.6 billion and claim a market share of 7.8%.
Trulicity is a glucagon-like peptide 1 (GLP-1) receptor agonist that helps the body release insulin more effectively. The drug won Food and Drug Administration (FDA) approval in 2014 for treating type 2 diabetes. Sales for Trulicity totaled more than $2 billion last year, with a global market share of 4.4%
Jardiance 14%
Boehringer Ingelheim and Lilly co-market Jardiance, which is projected to be the No. 3 best-selling diabetes drug in the world in 2024. The drug is expected to generate sales that year of $3.5 billion and capture 5.9% of the worldwide diabetes drug market.
Jardiance is the most successful of several sodium glucose co-transport (SGLT) 2 inhibitors. It won FDA approval in 2014 for treating type 2 diabetes and secured another approval in 2016 for reducing cardiovascular death in adults with type 2 diabetes. The drug made a little over $1.1 billion last year, with Lilly's portion of sales totaling close to $448 million.
https://www.boehringer-ingelheim.com/press-release/fda-approval-jardiance-cv-label
OUTCOME® trial, which investigated the effects of Jardiance® compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease.2 In the trial, Jardiance®significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo (HR 0.86, 95% CI: 0.74-0.99); absolute risk reduction was 1.6 percent for Jardiance® versus placebo. This primary finding was driven by a significant 38 percent reduction in the risk of cardiovascular death (HR 0.62, 95% CI: 0.49-0.77); absolute risk reduction was 2.2 percent for patients taking Jardiance® versus placebo. There was no change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70-1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92-1.67). The cardiovascular benefits of Jardiance® were consistent among patient subgroups.
Victoza 13% RRR
https://www.pharmacytimes.com/publications/issue/2017/november2017/r891_november2017
Very detailed call.
Do you like pina coladas........or geting lost in the rain...........
Chas, opening up your home to fellow board members is why I love this group! Real people with real passion for this company! Thank you for your gracious offer. I will be there in spirit!!!
Marzan, that is the $30 million 3.5% convertible to 7,716,048 ADSs, each ADS representing one ordinary share correct?
Dan, please add me shawn_mccormick@comcast.net
BB and group, where does this leave the Anchor Trial population for a label expansion? I remember from the 2013 ADCOM they wanted the R-IT Trial (no outcome data and failed previous outcome trials with niacin etc.) to support any changes correct? JT clearly has this now, why not go for it too?
What are the thoughts about the Achor indications? How will the FDA correct this error? I guess my question is will we also need to have a seperate adcom meeting to address this for an expansion of our labeling?
Great question O. I have wonder the same thing all weekend. I can see both sides but one thing is for sure is that AMARIN IS IN the the driver's seat now!!
Thoughts and questions I have this morning..........
1.) IMO they would share the data for serious offers ($15 to $25 Billion offer with NDL's). I think BB talked about starting at $30 a share and moving up. The data is the key to the price and JT's excitement on the CC leads me to believe it will be solid across all points!
2.) Is it also possible that Cantor Fitz has seen that data? Maybe that is why we saw the run late Friday after the private investors call they supposedly had earlier in the day? Plus we have their public presentation tomorrow that could add more details.
3.) Possible doing a small secondary after Nov 10th to raise capital at a much higher price?
4.) Posts on Cafepharma boards suggest new reps start dates of Oct 15.
I love the interactions on this board!!! For the last 5 years it has been great to read all sides. Thanks to everyone for their input and passion!
Here is the link:
www.medpagetoday.com/cardiology/prevention/75271