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Some "data" for the upcoming week.
Since January 1, 2013 we closed once at
1,95 (12/03/2013)
1,96 (01/02/2014)
1,97 (12/31/2013)
2,01 (10/17/2013)
2,02 (01/06/2014)
2,03 (10/18/2013)
2,04 (01/08/2014)
2,07 (01/14/2014)
2,10 (10/29/2013)
and never closed at
1,98
2,00
2,05
2,06
2,08
2,09
b-
Thx.
Look - I have several „reason”:
- First of all, I have time
- I do not think that anybody trying to think up a way to expose that any of my post as incorrect. It’s normal to check it, since except few most of the posters do not know anything about me top of my posts. If somebody challenges me with different assumption, I am fine with that, since I do not like Yes-Men and I do not think I am the only one who know the truth.
- Most of the posters add a value to the board (except three moderators, post like “As we are on this board.....hence, give it a rest re: scripts.”) and it is not a problem for me to accept different view, especially if I am not familiar with the given area. On the other hand I have experience in several area and I try to help others to understand the different topic. Yes, the situation looks gloomy now , however I just write down (translate) the facts, not generate.
I agree with most of your view, except: Pharmakon / BioPharma deal is (was) better than dilution, especially with this low (10%) Quarterly Cap. In case of other company BioPharma takes 25% of Net Revenue. If they made a mistake, it was that they did not dilute in the 10's - top of BioPharma deal – but I do not want to be back seat drivers, especially when I do not see (know) everything. I see one real mistake by the management only: they tried to approach OND immediately after SPA rescission. It was amateur / naive, since they could not work around the official way, so we lost 1-1.5 month, they had to try it simultaneously with appeal to DMEP. (I do not like the 2012-2014 Notes conversation - it was premature - but I do not know all details behind it.)
Hopefully, we will see the light in the tunnel - during the upcoming 1(2) week(s) - and it won't be the train (I still think).
f-
Read these posts: 31927 , 32060, 32082
"93000 reported scripts (btw on the endless subject of scripts, interesting that there's such a variance between IMS and Symphony numbers. Let's be conservative and use the lower number)"
The script number was 97,554 (“120 capsules” were delivered to wholesalers) – Method: (Revenue + allowance, discount, etc from 10-Q) / $195.04 (wholesale price).
The variance between IMS and Symphony numbers is not interesting, since these are just “best estimates”. They are using different statistical methodologies on different samples (ie.: IMS sample cover the 66% of the universe).
--------------------
Yes, maybe I was conservative with $126 / script, but it is affect the required script#, not the revenue. With $134,67 / script (average of the first two quarter) the required script # is 40,233 / week. (correction to $126 / script: required script # is 43,002 / week – I forget to take-off one non-cash item from OPEX, see the updated number below for $134,67 / script)
“Operating expenses $32.8 million” – it is $30,192 without non-cash item and KOWA fee (I calculated $341 for Q2 as KOWA fee, GM x 0,09 x 50%)
„Interest expense $4.2 million” – it’s $1,312. The $4.2 million contains non-cash items (ie.: “Debt issuance costs are initially capitalized as a deferred cost within other non-current assets and amortized to interest expense using the effective interest method over the expected term of the related debt.”)
“Assume 21100 weekly scripts X 13 = 274300 X $135 = $37,030,500” - ???- It is just equal with your OPEX assumption. Not covers interest, BioPharma, KOWA and COGS.
“It's true that Kowa is entitled to a share of gross margin over a certain level” – No. KOWA is entitled to a share (“the high single digits in 2014 to the low twenty percent levels in 2018”) of the total gross margin.
“on the other hand isn't gross margin supposed to increase due to API volume discount” – Yes, however I used the Q2 (60,14%) , since as the first time it was lower than the previous period (Q1 2014)
“$38 million of debt was "extinguished"” – Yes, but it is just accounting, non-cash item.
The revised numbers:
Assumptions (Based on Q2 2014):
Net revenue / script: $134,67
GM%: 60,14%
KOWA fee: 9% of Gross Margin
BioPharma: 10% of Net Revenue
Total Operating Expenses: as Q2
Notes interest: 3,5%
One-time expenses (ie.: $8.5 million license fee of ANCHOR to Laxdale) excluded
Break even script number: 40,233 / week
Total Revenue / $281,748
Cost of Revenue / $112,310
Gross Profit / $169,438
Research Development / $44,184
Selling General and Administrative / $91,829 (inc. $15,249 KOWA fee)
Total Operating Expenses / 136,013
Operating Income or Loss / $33,425
Notes 3,5% interest / $5,250
10% of NR to Biopharma / $28,175
I do not say it is 100% accurate (ie.:the net revenue is different in every quarter, since the allowance, etc % is different also), but we could say that with current GM% (60%) the break-even is 40-43k scripts / week.
Total Revenue / 287,849
Cost of Revenue / 114,742
Gross Profit / 173,106
Research Development / 46,908
Selling General and Administrative / 92,164 (inc. 15,580 KOWA fee)
Total Operating Expenses / 139,072
Operating Income or Loss / 34,035
Notes 3,5% interest / 5,250
10% of NR to Biopharma / 28,785
License fee:
"Also under the Laxdale agreement, upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing Amarin Neuroscience intellectual property acquired from Laxdale in 2004), we must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £7.5 million (approximately $12.8 million at June 30, 2014). Additionally, upon receipt of a marketing approval in the U.S. or Europe for a further indication of Vascepa (or further indication of any other product using Amarin Neuroscience intellectual property), we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $8.5 million at June 30, 2014) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $17.0 million at June 30, 2014)."
Assumptions (Based on Q2 2014):
Net revenue / script: $126
GM%: 60,14%
KOWA fee: 9% of Gross Margin
BioPharma: 10% of Net Revenue
Total Operating Expenses: as Q2
Notes interest: 3,5%
One-time expenses (ie.: $8.5 million license fee of ANCHOR to Laxdale) excluded
Break even script number: 43,933 / week
Hi JL & James364202,
Wegmans / Auto-Refill FAQs
How does Auto-Refill work?
When you have less than a week’s worth of medication remaining on your current prescription, we’ll automatically refill it for you. There is no need to call the pharmacy or stop in to the store.
We’ll give you a phone call to inform you that your prescription is ready to be picked up.
Just come to the Prescription Pickup Area of the pharmacy like usual!
What if my current prescription is out of refills?
Don’t worry! We’ll automatically contact the prescriber to request additional refills on your behalf. If your prescriber has given you additional prescriptions at an office visit, you can drop them off with us at any time. Once your current prescription runs out of refills we’ll begin filling from the new prescription.
A lot of good idea came up as a reason of the Refill number (ratio).
ie.:
- NRx includes renewals,
- off label and only taking 2-3 g
however these are true for other drugs also. I see two reason that could be Vascepa specific:
- side effects (we aren't aware of)
- insurance coverage
side effects: since it it is very well regulated - report to FDA, etc - I think it is very small, we did not see / hear any news about it
insurance coverage: We do not know the exact status and we know few consumer behavior. , so it could be the reason.
Based on 10-Qs/K and QCCs:
Q32013: Total life covered the 200 million, Tier 2 lives to over 92 million
Q42013: Total life covered over 200 million, Tier 2 lives to over 100 million. Tier 2 coverage exceeds 66% of the maximum level of Tier 2 coverage which has been achieved over multiple years by comparable
therapies.
Q12014: No update of numbers. "So we have seen in some cases the generic come on at Tier 1 and other cases it's not come on at Tier 1, we've seen some Lovaza move back out of Tier 2. But relative to Vascepa, where we're on Tier 2 unrestricted its remained on Tier 2 unrestricted." "So far, so good, but given, again, given our clinical profile and given our discussions with payers, we are not anticipating any major changes in the -- or any backward major changes in our Tier 2 coverage we continue to look to -- in fact we continue to expand our Q2 coverage and we're optimistic that, that will happen."
Q22014: No update of numbers. "In Q2, we did not witness any significant switching of patient’s from Vascepa to generic Lovaza and we continue to witness formulary coverage growth and tier-2 coverage growth from Vascepa after the launch of generic Lovaza."
They are not contradictory, since not the same, they could be on label together, just like in case of Trilipix (Exactly the same wording.)
You will see a lot of updates in later posts (including HSRN DATA BRIEF: NATIONAL PRESCRIPTION AUDIT™ linked by Pharmacydude), so I do not write it here, but one article from The New England Journal of Medicine: For Sale: Physicians' Prescribing Data
One example from the article regarding "the kind of detailed info you want":
"But a growing number of physicians have rebelled after becoming aware that drug companies have access to their data — in some cases because zealous sales agents have confronted them with their prescribing histories."
Yes, the number is not exact number, it is just a indicative, “best estimate” (including the total). Using a statistical methodology, projected based on sample (that is cover 66% of the universe). It is not reflect accurate number, but shows the trend, the app. breakdown of total into NRx and Refill.
The "issue" that while other drugs have near to 2.0 NRx:Refill ratio (ie.: Lovaza has avg. 1.8), Vascepa - within the same statistical model - has only 1.2.
a.) If Vascepa has the same ratio as other drugs it could generate 25% higher Gross Margin.
b.) the ratio suggest that 40% of patients do not take Vascepa after the first script and it is not good
Are you saying that the patients are fine to pay the 100% at the first (new) script and when it is less due to reimbursement, they stop it due to cost? It's strange for me.
"it is not an exact science": it's the same science as studies were analyzed - statistic. Sample size for the calculation is robust (66% of the total "sales point" - retail pharmacies (including chain/mass merchandisers, independent, and food-store pharmacies), non-governmental mail service pharmacy outlets and long-term care facilities, including nursing homes and nursing home providers).
Yes, it is good to see the continuous increase, but much better to see a higher weekly script number and increase, resulted in higher profit. Especially, when the market has a higher refill rate. It's not normal that 40% do not refill.
I hear you, the trend was clear till end of 2013, continuously increasing, however it's flat since January, stay within the 1.15-1.25 range and I think the insurance reimbursement affect the NRx and not the refill, since it is the same for both.
Lovaza’s average refill ratio is 1.8, meanwhile Vascepa’s 1.2. Based on last week NRx (4,161) it is a weekly 2.5k difference or $9.8M Gross Margin difference on a yearly basis (with net $126 / script and 60% GM), app. 25% higher than the current GM.
If we get ANCHOR and we will have (“just”) 50k NRx per week it is 30k difference and $118M as Gross Margin.
I think it is material.
ziploc_1: KOWA's right of first refusal is possible, makes sense.
P-
Thanks for the first hand info. It looks like my concern, incomprehension still exist.
Meanwhile app. 90% of patients refill their scripts for other drugs, it is just app. 60% for Vascepa. Looks like app. 40% stop it after the first month.
JL,
I am not arguing, I would like to understand. As I wrote: „I do not have a personal experience, all above based on my DD, so feel free to correct / amend me if necessary.”
If “The 2 additional months are not counted as refills. “, what type of script counted as refill?
If you write a script(s) for 3 months it is one “paper” or three?
funnygi2: Unfortunately not, the ratio is within the 1.15-1.25 range for a long period, sometimes near to 1.25, sometimes to 1.15.
-------
reg. SPA: I forget to mention that AMRN tried to approach OND immediately after SPA rescission (btw: it was amateur, naive, since they could not work around the official way, so we lost 1-1.5 month, they had to try it simultaneously with appeal to DMEP). Why did they try it? Since they - as me - did not expect a positive answer from DMEP and ODE II. Current level is the targeted level.
I also think there is a substantial chance they will reinstate the SPA at this level in the near future.. but hopefully in this month, during next (2) week(s).
I do not think that they will modify anything the SPA (it does not have any rationale). Based on the reinstated SPA they will (have to) approve ANCHOR indication as it is:
VASCEPA® (icosapent ethyl) is indicated 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.
CHD risk equivalents comprise:
- Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
- Diabetes;
- Multiple risk factors that confer a 10-year risk for CHD > 20%.
Limitation of Use will be on the label as:
- The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
- The effect of VASCEPA on cardiovascular mortality and morbidity in patients has not been determined.
If they would like some face saving modification they can do it on the label only (ie.: the exact wording of the indication, “highlight” the Limitation of Use, within the rest of the label)
I know that the weekly script number is not exact number, it is just a indicative, “best estimate” number, but it could show the trend and the “breakdown” to new and refill. (It is similar to TV rating.)
Companies - IMS Health, Symphony Health, etc. - buy electronic records of prescriptions from pharmacies and other sources and linked them with information about doctors that is licensed from the AMA, however they do not collect all data (ie.: IMS Health collects information on about 70%+ of all prescriptions filled in community pharmacies.) Using a statistical methodology, they project the total market (script number).
Scripts are counted based on pharmacies’ data and does not on doctors’ prescription. Every script are recorded in pharmacies as new or refill. When is it new or when is it refill?:
New:
- first time (new script)
- new prescriber, when the patient changed physician (I do not think it is a large number, since if somebody changed the physician, but has a “old” script that could be used for refill I do not see the reason to request a new script from new physician)
- new pharmacy for refill (I am not sure, since the pharmacy could recognize that it is a refill.)
Refill:
- after the first time (using the same script)
I do not know how the script recorded if somebody take more than 1 month (x months) at the same time. It could be all new or break down as 1 new and (x-1) refill, however the break down looks logical for me.
As I know not all but, the usual script is for 3 months, 1 new + 2 refills (ratio:2). I could figure out the following reason for the current new-refill ratio (1,15 – 1,25).
a.) the script is for 1 month only (and / or 3 months scripts prescribed, but all of the them is an individual script. This is the case here) – I do not think
b.) script for x months, buy at the same time: counted as x new – we need an info from pharmacist
c.) the patient does not refill – why?
I do not have a personal experience, all above based on my DD, so feel free to correct / amend me if necessary.
Sell because:
- while studies, news, etc. are supporting the reason behind R-IT, uncertainty is still exist regarding the exact result
- AMRN as an independent company could generate a nice revenue, but never the same level as a BP,
- BP could offer an acceptable amount for a TG >200 market (it is not a big risk as first in class product), maybe with a milestone payment based on R-IT result
win-win situation
Agree. As a first attempt they will try to work around, but finally they "have to" buy AMRN (not for patents only). I do not think that they will get any license from AMRN.
I do not think that anybody try to BO it before ANCHOR approval, however after ANCHOR approved I do not think that AMRN will reach interim / final analysis as an independent company, somebody will BO before end of 2015.
I see two possibility for the patent issue:
- dismiss, or
- AZN will be prohibited to launch it anytime
Continue your example reg. house / Epanova:
Top of it the building dept issue an order that you have to break down (write-off by AZN) the house. However you need a house, so you will look for a new land .....
The solution is easy, talk with me about science, studies ... and I will be silent.
La-
„… was a MISTAKE” – Short-term, yes – long-term: I do not think.
Taking $3.75 b … not to worry” Not questionable, it is easier.
Omthera did a good deal, however they did not have a choice since their product does not have a future. The big AZN could not launch the product 4 months after approval… I think it tells everything about Epanova …
Just try to “create” an example:
If you bought a land for 100k and “next day” you get offer about 110k. You could sell it, however if you think that you could build a house on the land within 2 years, cost around 100k and after that you could sell it for 300k, you will refuse the offer. After one year you will hit the wall since you have a problem with the builder and you already see that the cost will be more than 100k. But finally you could finish it and that time you could sell it for 500k (Not perfect, but hopefully understandable.)
“all we know JT is a puppet” – except me. Who is the puppeteer?
JZ: The company has Executive Team (3 members) to run the company on a daily basis and Board of Directors (8 members) to oversee the activities. JZ is not the Chairman of the Board he is 1 of the 8 only. So I do not think that he (could) running the show. Or do you think it was his decision to resign as a CEO … I could imagine it was part of the “deal” (resign) to give him a BoD seat.
FDA: FDA as every government office (in every country …) not homogeneous and everybody has to “fight” with a low level staff who are not genius (respect for the few). These people has a very strange ego: if they decide something, they stick to it till the last second, does not care the facts. Basically they do not run any risk, they do not have any real responsibility. (Otherwise, Eric Coleman would be prohibited to stay within 150 meters of any AdCom as a minimum …). JJ is the first person, that is more than a droid and as he involved MPC, he is not looks like “more than confident”. (As a side note: I do not think that they could release anything …)
If I am right reg. 08/14 we will see it next week. (If not it is not equal with no, I was just wrong regarding the date.)
ps: it is not really relevant, however February 20 was the last time when the closing at 1,94. The last 26 trading days was over 1M volume, all together 76,5M.
??? It is simple math: if you know any two of New, Refills or Total Script you could calculate the 3rd:
NRx + Refill = T
T - NRx = Refill
T - Refill = NRx
La-
First of all regarding: „regardless of what you think of me”. I do not have any think of you, since I do not know you. I have an opinion about your(s). I think everybody – except 3 posters (all of them moderator …) - add some value to the board, including you. I do not like to talk with a Yes Man, I like to see different view and I try to understand the logic behind it. Sometimes agree, sometimes not (especially when it is not logical to me or the fact is different).
Yes, I still FEEL that the SPA will be reinstated, chance of it is greater than no. Some reason is objective, some reason is subjective, ie.:
- recent studies,
- involvement of MPC
- high enough, but not too high level at FDA
- the first level, which was not directly involved in AdCom / SPA rescission
- price action
Maybe I am wrong, but it’s my impression now. We will know it soon.
I have a different view on pps than you. It was $1,65 three weeks ago and nowadays usually over $1,90. As I wrote more than 3 months ago the pps will be in the $1-90-2,10 (1,95-2,05) range before decision. This company does not worth $2,10-7,00 on a short term. It worth $1,5-1,6 (without Anchor) or (at least) $7+ with ANCHOR. “Nobody” (except JJ and the MPC ) knows the decision, uncertainty is exist. Top of this the pps is the market sentiment about the company, it is the current value, not a real value. It could be changed one day to other, just in case of other stocks (ie.: PUMA or PLUG).
Management: I agree with you that different management could handle the same company in a different way, however AMRN is a “special” case, I do not think that any other management could reach a different outcome of AdCom / ANCHOR. I could say today, when pps is where it is, – short term vs long term strategy - they did the right thing (no for $20- if any, GIA, etc. – except the 2012 Notes conversion to 2014: I see the benefit, however it was too early. If still necessary, they have to do it after JJ’s final reply.) Time will tell that we have right or not.
Maybe, announcement of new management could generate a pps jump, but only for a short-term, since companies are not valued based on management.
Finally, (I think we will never know any fact, so we have to base on logic): AMRN – FDA negotiation. I have two problem with the info:
1.) “SPA back on the table”- I do not see any scenario when the change of ANCHOR’s SPA in 2014 (after the study finished, analysis completed) change anything. DMEP rescinded the SPA, since otherwise they have to approve the indication (but not the label entirely !!!)
2.) “AMRN refused the BBW regarding no proof of CVE reduction” – They are talking about TG reduction in every doc, CC, communication, etc. only. FDA said, not AMRN during the AdCom: “…The only reason someone would be taking Vascepa in this scenario is to reduce the risk for cardiovascular disease. “, “to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease …. Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment”
AMRN said: “DR. KETCHUM: Yes. We factored in existing labels from other lipid-lowering therapies in terms of the types of parameters mentioned in their indication statements and/or in the data tables within the label. So that was the rationale for the proposed indication. Obviously, the application is still under review. We need to dialogue with the FDA team in terms of ultimately arriving at the label. But the hierarchy of the importance is clearly triglycerides without impacting LDL, and non-HDL-C.
If ANCHOR have been approved last year: Does the label includes BBW? The answer is yes. Without the BBW it is label of R-IT, not ANCHOR.
It could not be true, that AMRN requested a label that is not true, does not reflect the facts. They are running R-IT to get the proof and delete the BBW.
But OK – just for a second, theoretically – they do not want to see BBW at the time of AdCom, before SPA rescission. (call it as: nice try). Do they think after rescission they could win it on court? Answer is no. Maybe not the best management in the world, but definitely they did / could not think to get approval (without BBW) on court before end of R-IT, so if FDA offer: “OK, we will approve your indication, just include a BBW on the label.” they immediate answer is “OK, where could we signed?”.
Maybe I am wrong, but I guess my view is logical.
ps.: Everybody, please refrain from qualify other poster. You could agree or disagree with the post, but could not qualify the other, he/she has just other opinion than you.
Meanwhile I brought in the NFL as a topic I did it as a ps. Continue to post about it but as a ps only, not as a post.
Why the Nrx:Refill ration is 1,-15-1,25 and not the normal 1,75 - 1,90. (Theoretically the ratio is 2, since every script generates 2 refill)
As an example, the latest number was 4,161 (NRx) and 5,172 (Refill), ratio: 1,2430
Hi JL,
Did you ask your AMRN's rep regarding NRx - Refill "issue"?
Thx,
HDG
Ajax,
If I understand correctly, you said:
FDA agreed to approve ANCHOR as it was indicated,
"VASCEPA® (icosapent ethyl) is indicated 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."
including the "Limitations of Use" (The effect of VASCEPA on cardiovascular mortality and morbidity in patients has not been determined.) on the label. However, Amarin refused to include this limitation of use.
Is it a correct summary?
Ajax,
I still do not understand, how any SPA could be revised for an ended study, but never mind. It’s more interesting – if I understand you correctly – that the reason of this debacle was that Amarin does not want to include the Black Box Warning as “no proof of CVE reduction”?
“This would allow the Co to sell Vascepa for Trigs between 199-499mg/dl, but not allowing them to market it other than lowering Trigs. There would be a Boxed warning that Vascepa has not been shown as reducing CVE.”
It’s – for me and for sts66 (if I read it correctly) – full ANCHOR. I do not have any clue they would like to include “CVE reduction”. Everything is in line with the “label” above:
- definition of ANCHOR
- the indication
- they are running R-IT for proof
So, I do not see the rationality to refuse what they claimed. When and what we missed? How did you come to the conclusion that they want R-IT label now.
Sorry, but it is still unbelievable. (Maybe your source misleaded you.)
zumantu & mrmainstreet: Why is the proposed “label” above is a compromise? It is ANCHOR.
mrmainstreet & L0tsaluck2000: “tying approval to Reduce IT” – I guess Ajax mean: (ANCHOR sNDA) approval tying to R-IT (50% enrollment).
mrmainstreet – The first part is still true ? regarding Steelers But you have right, I missed it. The mea culpa addressed to „Dancing in the dark”. (Kiwi: it was the second ? )
Dancing in the dark: Mea culpa: the shelf is active, all of my speculation / idea regarding the delay amendment was a bullshit. (I do not understand why they issued the amendment, but it should be unimportant reason.)
LMAO ...you have right regarding the shelf, but totally wrong here.
Mea culpa: the shelf is active, all of my speculation / idea regarding the delay amendment was a bullshit.
(I do not understand why they issued the amendment, but it should be unimportant reason.)
I do not have nay proof that confirm that they get data in every quarter, however the DMC has a meeting on a quarterly basis.
JT said:
"And our enrollment to date, it's a trial designed around -- for 8,000 patients. We have over 6,800 enrolled, representing about 85% of the total. The mean and median baseline triglyceride levels for, you know, patients being enrolled in the study are north of 200 milligrams per deciliter, which is what we had wanted it to be. We think that that's the right pegging from a risk profile.
We are of course blinded to the results of the study. There is an independent data safety monitoring committee that regularly looks at the study from a safety perspective and regularly has, you know, gives us the thumbs-up for continuing the study."
Guidance for Clinical Trial Sponsors
4.3.1.2. Meeting Structure
" many DMC meetings include an "open" session in which information in the open report is discussed. These non-confidential data may include, for example, status of recruitment, baseline characteristics, ineligibility rate, accuracy and timeliness of data submissions, and other administrative data. Sponsors may also use open sessions to provide external data to the DMC that may be relevant to the study being monitored. Open session discussions might include representatives of the sponsor, steering committee, study investigators, FDA representatives, or others with trial responsibilities. There is a benefit to having a wider attendance at these sessions, since they provide an opportunity for those with the most intimate knowledge of the study to share their insights with the DMC and raise issues for the DMC to consider..."
-----------------------------
"FDA will reinstate the SPA supported by MPC recommendation on (or before) 08/14." - 08/14 as a date of MPC recommendation
La-
I know you said “SPA and Anchor” and not „Anchor AND SPA” or “Anchor's SPA.” I just assume you are talking about Anchor’s SPA, since it is the issue / topic nowadays. Maybe I am wrong and you mean MARINE’s SPA.
So, please clarify: SPA means SPA of Marine, Anchor or R-IT?
If it is Anchor’s: my question / request the same – “Please give me any example: what could be discussed in 2014 (after the study was finished, data was analyzed) regarding ANCHOR's SPA?”
If it is not Anchor’s: When was this take off from the table?
Hi Kiwi,
Thx, got it. I am not a physician ...
They also know the past trials of Crestor, so - I assume - it was build-in the 5,2%.
HDL not limited: Maybe.
As we know based on past, "HDL-increasing" studies, higher HDL reduces event possibility ... as AIM-High or HPS2-Thrive
Read as "(1) lower placebo rate" than planned.
Not really (if any will exist during the review). They will check the lipid-changes compared to baselines. If they will find any atypical changes (btw: it could not be atypical, since no other long-term, same type trial used mineral oil - I did not check it), they will come to the same conclusion as during Marine or ANCHOR: strange, but ok. We do not know the exact reason. The two arm comparison is the best method.
Agree, as I wrote earlier this level is high enough and not too high. (I guess(ed) JW and MH does not want to see anything "officially" on their desk, so the process should be end now ...)
They submitted the shelf registration request on 08/07 and the delay amendment on 08/15, one week later. Since I do not think they forget to delay, and the delay was necessary – not just an option - something had to happen between the submission and the delay.
The advantage of the delay is to keep the statement pending. In this way, the issuer and the staff can choose the registration statement’s effective date. I wrote about it in #32808 and #32841
Why is good to keep the statement pending?
a.) not necessary now
b.) fill an amendment
c.) “extend” the 3 years (financial gain is small, so forget it)
I do not think the reason is BO offer on the table.
- a.) fit to this only,
- BO is not a short process, so they did not know it within a week it will be finalized (unless the offer is $30+ ?
- If they think the BO will be agreed they could leave the new owner to do with the shelf what they want, delay is not necessary
I think they would like to fill an amendment to the shelf registration: change the prospectus. I could imagine one material reason only: change the Vascepa market / indication. Top of this – coincidence (?) – on 08/14 pps jumped $0,19 / 12%.
What could be the reason to change Vascepa indication and pps movement?
FDA will reinstate the SPA supported by MPC recommendation on (or before) 08/14.
Maybe I am wrong, however I could not imagine any other, realistic reason and I am not believe in coincidence.
ps.:
Dancing in the dark: Shelf is not active. SEC could not activate a shelf that is pending due to delay amendment, until the company issue a new amendment and as we know it did not happened.
They requested – and FDA agreed – the modification of R-IT’s SPA in May 2013. They increased the min. criteria for TG from 150 to 200 mg / dl. Around this time, the enrolled patients was app. 5,000 with a median 22 months follow-up.
The reason of the modification was the lower than expected event rate. DMC has a meeting in every quarter and they could see – and nobody else – the unblinded details. AMRN is receiving blinded, overall data / info (active and placebo arm together, not separated) on a quarterly basis. AMRN does not know the exact reason behind the rate difference: (1) lower placebo rate or (2) significantly higher eff.%
btw: As the lower than expected event rate was overall rate, I more confident that the planned 5,2% was also overall, so with 15% eff. the placebo was planned as 5,62% and active arm as 4,78%.