I am sure you have been told this before but you really have a way for going way out on a tangent.
"The day 74 letter likely included preliminary plans to hold an Advisory Committee (AC) but gave no date." You just make up what is likely included in a letter. This makes it an opinion and based on your other opinions it is nonsense.
Please retract the statement "The day 74 letter likely included preliminary plans to hold an Advisory Committee (AC) but gave no date. Notice the absence of any discussion of an AC from C-suite management since the 74-day letter?"
Not according to JT based on the Jefferies note:
Company continues to be bullish on accelerating market penetration and sales over the coming quarters. Co has noted the window for FDA to confirm any AdComm panel is narrowing, given priority review and PDUFA for Sep 28th. We think no panel and stock moves higher for straighter shot towards clean approval. In terms of patent litigation, a court date is set for Jan 2020....we think if any settlement comes, stock moves quickly higher towards $25+.
Insights
YTD the stock is up +42% (vs XBI +21%) as evidence of Vascepa's sales execution and potential (eg weekly script numbers) - continues mounting every week. Vascepa scripts recently hit record highs per third party data and even accelerated to +20% Q/Q vs +15% last quarter...all of this despite any formal FDA label expansion yet. Outside of Vascepa, the company has two key events/overhangs that could push stock higher towards $25+: (1) potential no AdComm could convince market that FDA has no major topics of debate and takes any headline or unpredictable panel risk off the table, and (2) clarity around generic filers as this uncertainty and patent decision in H1:20 makes it tough to own the stock for some investors, in our view. Hence for the stock, we think it goes higher on potential strong Q2 and possible guidance raise, pot'l no Adcom confirmation, and if they could secure a patent settlement by early 2020...so overall trend for stock is likely higher into year end....Trading risks seem to be: growing expectations on Q2 and risk/reward on prior quarters despite beats, panel is possible and stock pulls back despite panel highly likely to be OK, investor perception of further growing salesforce from 400 to 600+ at YE and upcoming DTC spend, no certainty on any litigation outcome.
Thus far, despite passing Day 60-74, FDA has not indicated whether it plans to hold an AdCom. We note there was no AdCom for the PCSK9 CV outcomes label expansion and AMGN was easily approved on time for their Priority Review too. Hence it's possible AMRN may not have a panel as there aren't any major debates here. We think 60% probability no panel and removes short-term headline risks. Mgmt commentary seems to be balanced noting FDA could always hold one to air public discussion, discuss differences of Vascepa vs other fish oils, and any relevance or not of triglycerides as a surrogate marker. Mgmt notes PDUFA is Sep so formal 55-60d notice to sponsor on any panel is coming up anyway by end of July...
Q2 looks good - note they could be increasing salesforce and preparing for DTC ads.. Scripts are hitting highs and math says we see Q2 north of $90-92M (vs cons $88M). Guidance could be raised on demand but also based on Standard Review not Priority Review. There is a growing view mgmt is preparing to pull forward and further increase salesforce from 400 to 600+ after PDUFA given promotional efforts are paying off and sales appear strong, and next is DTC being approved and planned for H1:20. Street probably needs to raise opex for 2020 for higher spend (but a positive to invest early) and there will probably be bull/bear investor debate on whether another salesforce increase and more opex spend is indicative of ongoing utilization.
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