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FDA's questionnaire at ANCHOR AdCom (Oct 2013)
FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), Silver Spring, MD
October 16, 2013
......
2. VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
Vote result: 9 No and 2 Yes
My comments
Nothing change yet! ANCHOR approval will be followed RI completion (or a stoppage on superior efficacy at RI 2nd INTERIM) -- i.e. prior to RI approval. Granted ANCHOR SPA was a mistake from FDA (or FDA hocking move for inducing AMRN to finish RI -- now AMRN is willing to cross the finish line for its own good).
Estimates -- Just FYI
Time__Cash____NetBurn_Revenue_TRx
1Q/14: $164.9M $27.6M $11.0M 93K
2Q/14: $151.1M $13.8M $12.6M 110K
3Q/14: $135.4M $15.7M $14.1M 132K
4Q/14: $119.5M $13.6M $16.5M 146K
1Q/15: $161.2M $30.3M $15.6M 154K
2Q/15: $136.0M $25.2M $17.7M 176K
3Q/15: $119.0M $32.3M $21.3M 199K
4Q/15: $107.0M $12.0M $26.4M 226K
1Q/16: $81.4M $25.6M $25.5M 239K
2Q/16: $72.5M $8.9M $32.8M 248K
3Q/16: $117.6M $15.8M $32.4M 245K
North
BA: bioavailability
BE: bioequivalence
Usually, looking at the matrix of Cmax (maximum concentration) and AUC (area under concentration-time curve) and judging by 0.90 confidence interval of Treatment/Reference within (0.80, 1.25).
The study itself is relatively easy -- only taking weeks.
The launch of 0.5g Vascepa in smaller capsule is a beginning of developing V/X Combo. The first COMBO should be V/Statin. Only BA/BE should be done for FDA's approval process. So, it may come out as early as 2H 2017.
"RI success" really is a U-turn for AMRN!!!! If you have any relative is on V, then ask them how they fill about V.
And, never say "never".
Seemingly, Citi (with readable analyses) wants to keep AMRN's low pps till RI outcoming positive RRR (their "30% success" may be "30% RRR"). PT $5 is just a joke for now ($2.6B equate to about $13 per share).
Prior to the earning CC, the PPS may channel around $3 (note-conversion price, $2.89, will pay as a floor).
Can Nov CC move the stock? I don't expect that. 1H17 would be the timing of starting reliable positives.
Be patient.
Do you intend to spread negatives on 2nd INTERIM as you did on 1st? (even if a stopage on 2nd is not a must)
FDA's goal was and is pushing AMRN reaching the RI finish line. It was not what AMRN's prefer at that time. But, now, it is AMRN's willing as well.
Originally, I was opposite to FDA as many longs. However, the three year's time changed my mind. Targeting such important indication of "preventing CVD", an outcome trial will be an ironic milestone. The light at the goal is already blinking. If RI outcomes are OK, I will keep my thousands shares (average below $2, thanks to the under $1 pps) for years.
Using V to treat COPD or ARDS is an excellent suggestion. And it may take a year or longer to achieve significant efficacy, and the mortality rate of COPD and ARDS is quite high. So, the treatment should be started ASAP.
Seemingly, we are interesting in the following correlations:
A) Whether there is a significantly positive correlation between in-vivo EPA level and in-vivo triglyceride level.
By Anchor, the answer is a strong YES.
B) Whether there is a significant positive correlation between in-vivo triglyceride level and CVE frequency.
YES, theoretically; but "not sure" practically -- Triglyceride level alone is not enough.
C) Whether there is a significant negative correlation between in-vivo EPA level and CVE frequency.
RI intends to get Answer C. Suppose to be a strong YES, but we have wait and see. Fortunately, not too long to wait. I am long in C.
See Page 24
www dot fda dot gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM293268.pdf
such that P-IV ANDA was firstly filed on 7/26/2016 (by Activa -> AGN). The two Indian are just followers. However, we have not seen any patent-fight launched wrt Vascepa. Perhaps Activa's P-IV filing was not been "received."
By my understanding Nov 8th is still a date to watch whether AMRN will launch a patent fight (if not, the Indian Jones may got stuck as Activa as well).
Or someone can email IR to ask about the issue.
So, two Indian companies filed P-IV challenges to genericizing Vascepa. But the market gave a Quarter to each AMRN's common.
My reading is that
Mr. Market hate uncertainties. Previous, some thought V may be treated as a DS material. Today's P-IV filings said V is a solid DRUG and the patents are working till its end.
AMRN will commence the patent fight on November 8th. Usually, a patent-fight would be ended with a compromise of allowing the P-IV filers entering the market before patent expiration (2020 or 2030 for V, I prefer 2030).
The fact of low PPS was primarily attributed by the uncertainties. Removing some uncertainties will help for reevaluating the PPS.
Funny!!!
You have 50% chance to be right and you have 50% chance to be wrong. Really everyonesguess.
Results are anticipated. Trading volume is calm. PPS is around the "notes conversion". Nothing to be sad about and nothing to be exciting about. At least, a "futile" has been filmly ruled out.
The question is: the second INTERIM will be similar or not?
Seemingly, the company is preparing for a BO.
The story of PFE's $19B BO of Medivation tells that a BO is waiting for AMRN with any success of RI -- Vascepa will be a wonderful drug in many popular indications. If the INTERIM shows any positive outcomes (not necessarily "stopped"), the BO rumor will firing the rocket.
"$3.25 Wall"?
Seemingly like a stone. But it will be a piece of thin paper with any positive INTERIM outcomes.
If the coming INTERIM will be "so" good (as many posted here), why the company set up the second INTERIM. Any creditable explanation? Current low PPS present worries.
Cash Burn for 3Q/16 will be $8.9M or more (with aggressive promotion).
3Q/16 COH expectation changed due to underwriters purchased additional shares:
Time__COH___NetBurn_Revenue_TRx
1Q/14: $164.9M $27.6M $11.0M 93K
2Q/14: $151.1M $13.8M $12.6M 110K
3Q/14: $135.4M $15.7M $14.1M 132K
4Q/14: $119.5M $13.6M $16.5M 146K
1Q/15: $161.2M $30.3M $15.6M 154K
2Q/15: $136.0M $25.2M $17.7M 176K
3Q/15: $119.0M $32.3M $21.3M 199K
4Q/15: $107.0M $12.0M $26.4M 226K
1Q/16: $81.4M $25.6M $25.5M 239K
2Q/16: $72.5M $8.9M $32.8M 280K
3Q/16: ~$154M
Current COH is enough to support additional promotions.
The company will increase its sales force to 500 Reps, so they need cash and get it.
According with 1A settlement with FDA, the company can immediately promote upon RI outcomes.
See COH for yourself.
Time__COH___NetBurn_Revenue_TRx
1Q/14: $164.9M $27.6M $11.0M 93K
2Q/14: $151.1M $13.8M $12.6M 110K
3Q/14: $135.4M $15.7M $14.1M 132K
4Q/14: $119.5M $13.6M $16.5M 146K
1Q/15: $161.2M $30.3M $15.6M 154K
2Q/15: $136.0M $25.2M $17.7M 176K
3Q/15: $119.0M $32.3M $21.3M 199K
4Q/15: $107.0M $12.0M $26.4M 226K
1Q/16: $81.4M $25.6M $25.5M 239K
2Q/16: $72.5M $8.9M $32.8M 264K
3Q/16: $120M
AMRN would be $4 per share at the end of August.
If the company can keep low cash burn ($8.9M for 2Q) and higher TRx, I don't think a dilution is in the card.
Time____COH___NetBurn_Revenue_TRx
1Q/14: $164.9M $27.6M $11.0M 93K
2Q/14: $151.1M $13.8M $12.6M 110K
3Q/14: $135.4M $15.7M $14.1M 132K
4Q/14: $119.5M $13.6M $16.5M 146K
1Q/15: $161.2M $30.3M $15.6M 154K
2Q/15: $136.0M $25.2M $17.7M 176K
3Q/15: $119.0M $32.3M $21.3M 199K
4Q/15: $107.0M $12.0M $26.4M 226K
1Q/16: $81.4M $25.6M $25.5M 239K
2Q/16: $72.5M $8.9M $32.8M 264K
As of 6/30, they still have $72.5M Cash and only $8.9M burning for 1Q. And the sales is ramp up. Sales force is expected to be up to 500 Reps (now only 130 at AMRN, and KOWA's are "lazy"). I believe that no dilution in sight. Somebody who is waiting for a dilution to buy could be waiting along the sideline forever ;)
From the CC, there will be 2 INTERIMs for RI: 60% and 80%. The first INTERIM will be released in Sep/Oct 2016. I believe that second INTERIM will be in 2017 summer. I expect ~$6 at the First and ~$12 at the Second.
I believe that many of us expect tomorrow will be a day of battle. For the CC, I am interesting in Cash Position most; for the trading, I am interesting in VOLUME most -- if volume tops 30M tomorrow, everything else would not be a problem.
I think that 5K+ Oct $4 Call could be a heg of short (with current jumps with volume, there should be quite many shorts).
Speaking of Patents, by Composition Patents, any generic EPA approaching to a certain level of purity (say, 90%) is a violation of AMRN's patents -- V itself is as 96% EPA, plus RI is an outcome trial. Therefore, any generic EPA has to show efficacy equivalence of V but cannot have high EPA purity. Therefore, I doubt any challenger can have a reasonable P IV certification to convince the FDA (if not corrupted) to accept it.
Good for you.
I remember, 2013 AdCom hit many very hard (lost $M, say, doctorofinvestor and speedrunner). It was a FDA-Coleman hit (God bless Coleman). At that AdCom eve, pps was down to about $6 from $12 (a few weeks ago of AdCom). Now, it is history.
I think, $6 is on the horizon now, and $12 will be coming in 2017. I don't have a sight of post $12 at now -- we have to watch the face of Scrip (if 18K, weekly, upon INTERIM and 20K by yearend, then $12 will be a potato).
Seemingly, $3.33 at tomorrow's close. The day after tomorrow may be a fire-work day: the Q2 CC day. I am interesting in funding situation most. Enough case is the #1 issue.
Thanks M.
$3.33 was Baker Bro's High. $6 was AdCom's Low. Higher High plus higher Low can drive the PPS upwards for a while.
Everyone's Guess: what is today's close, $3? Then, what will be RI-INTERIM-day's close, $6?
$3 is a critic PPS. As PPS above $3, longs will gain more buying power (with most brokerages, above $3 is the threshold of "marginable"). I believe that we will see $3 in August, and see $6 with positive INTERIM (not necessarily be "Stopped").
No company announced a P IV filing on 7/26 doesn't means nobody filing. Indicated by NCE, the P IV challenge would be very complicated. Even there was a filer (intending to be the First Filer for 180 day marketing exclusivity), the filer may be waiting for FDA's acceptance silently. FDA has 30 day review period, and FDA usually announces the result at the end of the 30 day review. If FDA accepts (usually does), the company has 45 day to launch a patent law-suit. So, be patient. I think that is one reason why the company plans to release RI INTERIM in Sep/Oct (If no P IV Filing, the INTERIM release would be in Sep; otherwise (with P IV) in Oct -- JMO.
Tomorrow will be the opening date for a P IV ANDA filing against V. FDA accepts the ANDA Filing(s) or not will be posted within 45 days (usually "accept").
Indicating by today's 3C gain, the market seemingly doesn't concern it yet.
Oct 21 $1 Call bid/ask at $0.05/$1.85. If a buy can be made at $1.45, it seems good to me.
I used to buy in-money Calls EARLY (then become cheap later, if the stock goes to the right direction). Do doing a lot of home works. Yes, finished with empty hands a few times, but rewarding significantly with others. To sum up, Options give me better return than Commons. Disclosure: I own 600 contracts of 2017 Jan $0.5-$1.5 Calls (primarily bought in late 2016) plus a few dozens others (bought recently).