AI
Friday, September 05, 2014 2:07:59 PM
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.
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.
