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No, not active.
I could not send a PM, so if you could send your email address and I will send a blank email to u.
“The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.”
My reading: the new amendments become effective
a.) in accordance with Section 8(a) of the Securities Act of 1933 - it's max 20 days (automatic effectivness) or
b.) on such date as the Commission acting pursuant to said Section 8(a), may determine - it could be less than 20 days
With delaying amendment to the registration statement issuer keep the statement pending. In this way, the issuer and the staff can choose the registration statement’s effective date.
BB,
The shelf accepted, but not in effect since they submitted delaying amendment on 08/15. It will become effective if a company submit new amendment.
Regarding this item AMRN did not submit anything, it was a SEC generated doc.
BB,
The case is about NME vs NCE (or about the period between 07/26 2015 -2017, timing of filling / acceptance of ANDAs). In both cases - NME & NCE - the exclusivity period started on 07/26/2012. Amarin could use the same argument as Eisai Inc. since they could immediately, legally market Vascepa based on approval.
NCE is not linked to indication it is to product. The NCE start on the date of NDA approval. All additional indication (ie.: ANCHOR) is sNDA.
I reply, react to any post after I read all of the unread items ...
I am not 100% sure, but I think the shelf is not effective it was just accepted by the SEC.
Securities Act of 1933
SEC. 8. (a) Except as hereinafter provided, the effective date of a registration statement shall be the twentieth day after the filing thereof or such earlier date as the Commission may determine
Sec.473 - Delaying amendments
Securities Regulation, Quinn - Fall 2004
Process of SEC Review
a. § 8 gives the SEC the authority to review the registration statement.
1) Subsection (a) says that the registration statement becomes effective 20 days from filing it. Any time the statement is amended the 20-day wait period starts over.
2) Subsection (b) says that prior to the effective date, the SEC can issue a refusal order if registration statement appears incomplete and inaccurate.
3) Subsection (d) says that at any time, the SEC can issue a stop order.
4) Section 8 gives SEC authority to shorten 20-day period amendment. This is done through Rule 473. Registration can become effective on such earlier date determined. The Commission can accelerate effectiveness.
b. Rule 473
1) Includes language-delaying amendment. Don’t have to file an amendment every 20 days to keep the process going. Solves problem about automatic effectiveness in 20 days. This process is called acceleration because the Commission can accelerate the registration statement’s effectiveness.
a) Acceleration allows an issuer to add a delaying statement to the registration statement to keep the statement pending. In this way, the issuer and the staff can choose the registration statement’s effective date.
Anchor sNDA005 with exclusivity - There will be no exclusivity for Anchor. Indications could not get exclusivity the drug itself (Vascepa) could. NCE legal case not related to sNDA005, so it could not conflict.
If - and I think yes - the Judge's decision will be favor of Amarin, it will give five years exclusivity to Vascepa till July 26, 2017.
Shelf: I am still checking it.
More specify:
Ladies and gentlemen, fasten your seat belt, prepare for take-off please. We still have red light, but we will get the green during the next 20 seconds (days). I wish you all an enjoyable experience. See you soon in heaven (or in hell).
Hi lad,
shortly, since i am sailing: what todays pps tell to you...
NCE: It is still ongoing, but based on other cases - yes, I am optimistic ( see #30800)
SPA: I would like to use word likely than obvious.
The PPS is 20% higher tan 1 month ago - except today untill now - it keeps the Aug 14 level.
Additional increase: maybe yes, maybe not. Just see two of us: I think the answer will be yes, you think it will be no. I do not have any evidence, it is just my "conclusion" / assumption. And we have to take into account - due to unexpected, weird past - that any expectation has much limited effect in case of Amarin till official announcement than in case of other companies.
I do not think that he is writing, but my experience that the final version takes more time if somebody else write it ... As I wrote this week could be enough to finalize, so it could be released anytime after 08/25.
To anwer to JJ MPC has to held a meeting.
Formal Dispute Resolution:
Appeals Above the Division Level
"In instances when the FDA requires limited discussion with one or more members of an advisory committee or internal or external experts, the FDA should inform the sponsor of this plan within 30 calendar days from receipt of the appeal. The FDA should schedule such limited discussions as quickly as all parties are able to agree on a mutually acceptable date and time. After this limited discussion is held, the FDA should render a decision on the appeal within 30 calendar days from the date of the discussion."
JJ action suggest that he has at least some doubt regarding the rescission.
Yes, he has the authority, but it's "complex" now (ie.: Senate/ House interest, first SPA rescission / reinstatement (?), new studies) and - maybe - he do not want to make a "one man show".
I am still belive that the MPC meeting was held last week, since the decision expected mid-Sept and next week is too close to that. (This week the head of MPC is out of office.)
I did not expect the official answer this week, but it could come on any day between 08/25 - 09/12.
First of all the answer is yes - all circumstances together suggest the SPA reinstatement (for me).
Agree the 80-90% drop is terrible, however if you check the reason case by case (BO, ANCHOR SPA, NCE) it is nothing special. It could be easily at or near to the same level after ANCHOR approval.
I do not expect higher than 1,90-2,10 PPS (I wrote it down months ago) before ANCHOR approval and the current level is not worrisome – still 0,1-0,15 higher than 1 week ago or 20% higher than 1 month ago. Unfortunately expectation is not enough for $s jump, since both ANCHOR SPA and NCE decision were at least weird. (btw: NCE will be overturned by the court as I wrote previously, based on other FDA NCE legal cases: moiety vs ingredient – regulation vs statue.)
Hi Kiwi,
The Notes could be converted to shares without the shelf, since the shelf is for public offering. AMRN could issue new shares since "Common stock, £0.50 par, unlimited authorized" (latest 10-Q).
Delay of the shelf:
- the reason should be material and unofficial , since otherwise they have to issue 8-K as material event
- I have 2 idea regarding the reason:
a.) they think based on new info that the registration is not necessary now
b.) (It's came to my mind now) based on new info they would like to change the prospectus, when the info will be official ...
For both (a and b) I could conclude one info only that is big enough to suspend the shelf .....
ps.: BioBill, AZN submit the sealed document on Monday, 08/18 and not on Fri 08/15 (as I remember)
Agree with your doubt. A lot of reason could be behind sealing, but definitely not a negotiation or BO, since these could not be one side statement.
Shelf on hold: The reason behind it should be exact and I assume that AMRN became aware of it on Aug 14 …
What is?
Yeah, but back to our original discussion: AMRN does not have to pay interest related to deferred payment. Are you agree / accept it?
Kiwi,
I have my own glass of wine also , BUT:
1.) Holder could exchange at any pps, $2,86 is a minimum limit for Amarin to exchange !!!!!
2.) 12-14 %: I remember for the number, but could not find it. Definitely not as a interest rate for deferred payment. What is the source of it?
Hi Kiwi,
Did you take all of my correction?
Best,
G
Hi ladavis23,
First of all my current odds currently: 65% reinstatement, 15% Working Group (delay), 20% no. I give a good possibility to reinstatement since science, logic, interest of patients suggest it … (I am long, but if JJ will uphold the decision I will use my investment somewhere else – at least - in the next 18 months, since 2 level (JW & MH) are before court. Shortly denial is negative since AMRN could not jump over the remaining two level to go to court)
I do not want to argue that it is a minor league management or not, since it is irrelevant. The whole story is about Vascepa. I agree with you that new management re-energize many participants, BUT it is temporarily, since none of the companies about management, it’s about product (in this case Vascepa).
Hi BB,
Some thought:
Valuation: My view that the valuation mainly reflects the future value / possibilities and not a current value of the company. (ladavis23: If market / price “reflects” the management why companies’ pps are moving significantly up or down with the same management?) The current value assume that they will have financial problem sometimes due to script level and Vascepa current indication. It will be significantly different if: SPA reinstated / ANCHOR approved. I do not say that BO offer will come immediately, but the possibility will be higher. In case of BO, the buyer buy the future and the past.
If ANCHOR approved, it not makes sense (just a short term “gain” vs long-term gain) for Amarin to cooperate with anybody for anything top of current co-promotion with KOWA. I also think that the SF will not be increased immediately, first of all they have to monetize the expanded indication.
R-IT: It not makes sense to increase the enrollment, since the follow-up period will be longer, it will takes more time to reach the median 4 years.
AZN: I do not think that they will license any of the patents. It worth more as own right then the license revenue and do not forget they could not do it without BioPharma, since patents are collateral.
Kiwi,
I hope you do not mind, but I „have to” correct some points in your posts 32549 & 50:
1.) Issuer, Holders
Corsicanto = Amarin, since it is the wholly-owned subsidiary of Amarin. CORSICANTO LIMITED, was the Issuer and AMARIN CORPORATION PLC, was the Guarantor for the 2012 and 2014 Notes (both: “Notes”). We do not know who the Holders are.
2.) Notes debt payment (partially corrected in 32550)
Amarin does not have to pay any debt now. The current payments are interest only (5,250k in two instalments). The first debt payment if requested by the Holders – will be 2017 for 2012 Notes and 2019 for 2014 Notes. The maturity of the Notes is 2032.
3.) Notes exchange:
HOLDERS right (not all, just the percentage)
2012 Notes: “… after March 31, 2012 ... (“ADSs”) for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days … is greater than or equal to 130% of the exchange price on each applicable trading day;” The basis for 130% is $8,81 and valid for 3,547,916 shares
2014 Notes: They do not have any limit they could exchange anytime at any PPS. Valid for 45,666,925 shares.
2012 & 2014 together: 49,214,841 shares
4.) $2,86 (110%)
This is the limit for Issuer / Amarin to exchange, not for the Holders.
5.) Patents
The owner of the patents is Amarin. “the Company granted BioPharma a security interest in the Company’s patents, trademarks, trade names, domain names, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoing and all proceeds of the foregoing, referred to collectively as the collateral” BioPharma will never own the patents they just entitled to sell it under certain circumstances (ie.: bankruptcy of Amarin)
6.) BioPharna interest, payment, cap
As the latest 10-Q: “In accordance with the agreement with BioPharma, quarterly differences between the calculated optional reduction amounts and the repayment schedule amounts are rescheduled for payment beginning in the second quarter of 2017. Any such deferred repayments will remain subject to continued application of the quarterly ceiling in amounts due established by the calculated threshold limitation based on quarterly Vascepa revenues. No additional interest expense or liability is incurred as a result of such deferred repayments.
Contract: "Any reconciling payment made pursuant to this Section 2.1(d) shall be made without interest pursuant to Section 2.4."
They will never pay a interest. It’s already included in the $150M since they got $100M only. They will pay interest if they not pay on or before due date. Contract: "2.4 INTEREST. In the event a payment under this Agreement is not made when due hereunder, the amount of such outstanding payment will accrue interest (from the date such payment is due through and including the date on which full payment is made) at an annual rate equal to [***]. Payment of accrued interest will accompany payment of the outstanding payment."
Correct me if I am wrong, bur do you suggest that AZN and AMRN are talking about some form of cooperation and that the reason for sealing?
I think if that the case (I do not think) they have to request a "delay" together. AZN could seal anything (with court permission) and usually court does not refuse sealing request.
Kiwi,
I could not say that Cap (10% of Net Revenue) will be same always, since it is [RESERVED] in the contract, but 100% sure:
1.) the Quarterly Amount depends on Net Revenue and not linked to cash balance
1.) they have a Cap during the Payment Period (and the Payment Period is ending when they fully paid the $150M)
1.a.) The Cap exists in and after the first Calendar Quarter of 2017 also
A shelf registration statement is simple a technical thing (and valid for 3 years). Based on that they could issue offering and there is no delay in waiting for the SEC to possibly review the prospectus or the terms of the offering. - submitted on Aug 7. However on Aug 15, they delayed / suspend the self registration, so currently they could not offer new shares (Note: they could exchange the debt to shares without SEC / shelf / offering if Holders want it). The reason of this delay could mean many thing, including:
- they find a different way to get money (as BioB think)
- they know it is not necessary since they do not need new money in the near future and they do not want to use any day from the 3 years (as I think)
and as I read your question I realized that the delay was 1 day after Aug 14 ... I still think that the MPC meeting was held last week and their recommendation is positive for AMRN (I could not find any exact reason behind 08/14 jump). So maybe (MAYBE) they get some (unofficial) info regarding SPA / ANCHOR ...
Meanwhile ... Kiwi: I think if ANCHOR approved they do not have to use the shelf, they could finance the operation & R-IT from scripts.
My strategy: Sell it after ANCHOR approval, during short squeeze, BO rumor around $13-15, before it go down by $3-4 due to Notes exchange and no BO announcement
Hi birzinho,
The 130% is in the 2012 Notes (100% = $8,81) as part of the Holders exchange condition.
The 110% ($2,86, 100%=$2,6) is in the 2014 Notes as Issuer exchange condition. (Issuer is Corsicanto wholly owned company of Amarin). (Kiwi: $2,86 for Issuer and not for the Holders !!!)
Yes and no.
Yes: ANCHOR study was finished.
No: R-IT was not enrolled in 50% (and FDA could approve requested indication only)
Thx,
Of course it is just a guess (hope), but not new (#28417 Friday, 05/30/14 05:43:11 PM) Unfortunately, I am not within the few who has inside info from FDA but I think "signs" are promising. It’s not a 10-Q or a contract, that could be analyzed based on facts, but:
- the current situation is absurd, non-sense
- answer expected mid-September and acc. to guideline FDA has 30 days after ’event’ to send the answer: so the meeting should be around mid-August
- Thursday (Friday) price movement: It was more or less the same as July 31. It fits to my calculated deadline (Aug 1.) for OND to send the answer. I think JJ sent the “delay / MPC” answer on that day.
- My guess: Thursday movement belongs to MPC (positive)recommendation
Jump over $7 / $8 or more.
It will be two phase: SPA reinstatement and x days / weeks later sNDA decision / ANCHOR approval.
Based on Niaspan’s, Trilipix’s label and proposed ANCHOR indication I expect something like this as a label:
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated
• as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia.
• as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo-B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent when treatment with statin monotherapy is considered inadequate.
Limitations of Use:
• The effect of VASCEPA on the risk for pancreatitis has not been determined.
• The effect of VASCEPA on cardiovascular mortality and morbidity in has not been determined.
Exactly.
But I think we will not see $4,24. Below 3 it will jump over 7/8 after SPA reinstatement and ANCHOR approval.
My guess that the MPC meeting was held last week. The question is: JJ will wait 30 days or send the answer earlier? I do not expect it during this week, but from 08/25 it is possible on any day.
$2,86 is for Amarin it's not for Holders.
Original 2012 (150M): 17,021,280 shares /$8,81
after exchange:
Remaining 2012 ($31,266k): 3,547,916 shares /$8,81
New 2014 ($118,734k): 45,666,925 shares /$2,60
The interest 3,5% and app. 18 years till 2032 (3,5x18=0,63), so if Holders convert (the 2014s at $4,24, the 2012s at $14,36) they collect the 100% capital and the interest for 18 years immediatelly ...
I don't have any idea who are the Holders.
However (theoretically, just for fun) if it was the only way – exchange 2012 Notes hold by RENAISSANCE TECHNOLOGIES LLC into 2014 Notes – to get ANCHOR now I revise my opinion and it was one of best deal in the world …
IF the Holders will not convert ... Convert by Amarin makes sence if the ANCHOR not grandted and / or they could not increase enough the script numbers. If ANCHOR granted and / or scripts will be significantly higher I do not think they will convert it. But I think in this case the PPS will be much higher and Holders will convert.