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Thank you kindly for clarifying that receipt date is submission date. That’s what I couldn’t find before.
Thanks for replying. Yes I know that. In fact I asked the question a week ago (post 170679) what difference it would make to the response time following the application and/or the review time. No one replied with a pertinent response, unless there was a response not directed to me and I did not see it.
Trying to extract information from the FDA website is worse than dental surgery when it’s not safe.
That’s a little earlier than possible. Here’s the timeline for tafamidis:
Topline results March 2018
Granted breakthrough therapy designation May 2018
NDA submitted Q4 2018, probably two months ago
Priority review granted January 2019 with PDUFA date six months from then.
I think the end of October 2019 is the earliest we could receive approval unless the FDA acts way outside their box. The end of November is more likely if we submit the NDA at the end of Q1 and receive priority review two months later.
There’s no doubt that the BOD and the Baker Brothers can veto an offer, but as I understand it only overwhelming approval by the shareholders can accept an offer.
If there is a deal for stock or cash plus CVR, until the deal is closed the CVR does not exist, and therefore the value the market attaches to the CVR will be part of the share price. it will be like an ex-dividend event. So, if the deal were announced I don’t think the record date would be before March expiration and therefore if the March 30 call had intrinsic value of $10 after the deal at $40, and the market thought the CVR value would be $20 then the call value would be $30 at expiration.
By the way a deal that low will not happen.
The above is all my own opinion.
I have not been able to find the definition of “receipt date.” I did find that priority review is, as you stated, “receipt date” plus six months. I don’t know that the two month response period, after which the sponsor is informed whether he will receive priority or standard review, establishes the receipt date and starts the six-month clock, but I do know that the expected PDUFA date is generally provided in that response letter. If otoh receipt date is very quick after the electronic submission of a non-nme application, an electronically recorded date, then the priority review PDUFA date could be six months after that electronically recorded date, which would be effectively six months following the submission. Then if our sNDA is submitted just before the end of Q1 then we would expect priority review and approval just before the end of Q3.
My question is specifically on the receipt date for non-nme applications, since I saw priority review for nme applicatios described as two months plus six months.
BR, you’ve posted that twice now, yesterday and now today. Looks like you want everybody else to sell because I don’t think you have a long position. Why not just come out and say you’re short.
You know Senator Warren too?
They can’t split by indication so the only way for a multiple party buy-out to work would be by regional exclusivity, for example, US and Europe owned by separate parties
Think again about anyone over 70 having a ROTH. I’m 75 and have had a Roth since at least 2001.
It looks like Professor Jane Armitage from Oxford either oesn’t get it or has a reason to try to shade the awesome results from Reduce-it. It’s not about triglyceride lowering, Professor, but then you should be able to figure that out.
Down 300%? The only way that could happen is if you put up 100 grand and lose 400, owing your bookie 300 grand.
I have Silverscript Choice in California as my part D drug plan. and Vascepa is tier 4 for me, 50% of total cost in January and 5% of total cost in December when I’m on the other side of the donut hole.
Thank you very kindly.
Amarin should provide a response letter for that kind of crap. It’s almost criminal malpractice coming from the PBM.
I am a paid member and message options Include “keep/unkeep.”
Unfortunately, I think third grade arithmetic is more like rocket science to today’s students. They know how to push the buttons on a calculator or smartphone but have no sense of numbers that comes from doing arithmetic manually.
Thank you. I grabbed that particular slide and added to my Vascepa folder, even though I already had the whole presentation there.
Now, does anyone know how to access the “kept” messages on iHub? I’m not seeing that tree in the forest of information.
I can’t seem to find the post with the MOA benefits list mentioned in 7) on this post. Perhaps I marked it as “keep” and the problem is I can’t figure out how to get to my “kept” posts. I don’t see a link except to keep or unkeep any post as I am reading it. The lawyers here would tell me I’m asking a compound question: 1) where is the list of moa benefits? and 2) how do I get to my list of kept posts? Thanks in advance for any help.
I might suggest that the moa benefits list should be a sticky post.
I agree. I’ve been thinking the same thing ever since talk about Strength became rampant. It’s the big “what if.” What if the corn oil negative effect made it look like the treatment arm had a great positive effect? In this case, unlike in the MO case, I think the concern is justified.
I don’t remember seeing in your home statement at the website that the pages will be updated frequently as questions and responses arise, so everyone should check frequently for updates. Without such a notice I think many people might look at it once and then when they see the link in the future say I already looked at that.
Whether or not that sort of idea is already incorporated, thank you for your major contribution here.
I suggest one small but important change. Keeping in mind that Vascepa is not fish oil, the fish oil pill should not be captioned “other fish oil pills” but rather “fish oil pills”
You still don’t get it. T/A does not predict. It suggests possible outcomes, with varying probability based on what happened on prior occasions showing similar charts. Perhaps you should ask yourself why you spend so much energy ridiculing/trying to demean FFS rather than just disagreeing with him and either saying nothing or saying little. Arrogance and superiority are not attractive qualities.
Wow! I want to buy stock in your entrails supplier.
I often refer to weathermen and weatherwomen as weather liars, but I do so calmly, knowing that their charts are showing possible or even probable outcomes, but not predictions. FFS and other TA practitioners are doing the same, showing possibilities not predictions. The probability is suggested by what has happened at other times with similar charts.
I find personal attacks on a message board say more about the attacker than the attackee. For some reason there are people with such fear of TA that they attack the TA proponent. They will come back at me now and said no they don’t fear it but they know it’s wrong. That retort does not explain the anger behind the attack and I think those people should look in the mirror. If they just disagree with the TA then there could be a calm disagreement not a frenzied attack.
If we invert that p-value expression it states that the odds are 100,000,000 to 1 but the results are accurate and not a fluke.
I think he was careful not to specifically exclude DTC before label expansion. What he specifically said was it’s more tricky than educating doctors.
Wondering if we don’t need to register a few dozen sites, the reason being that the opponents may try to obfuscate the space when they see the info site launched and maybe we can set up a more defensible perimeter Iby having some similar names already reserved.
That is not correct. Both long and short opening transactions add to the open interest. Both long and short closing transactions subtract from the open interest. So according to Dan, the $18 call was sold and the $25 call was bought.
If I read Dan’s post correctly, they are not at all bearish. They sold the call spread to a client to accommodate his wish to make more upside, and their risk of being short the spread is completely covered by the green shoe.
Dan, do I have this right?. Looks like you’re suggesting a client who bought shares at $18 from the offering also bought the $18/$25 spread to get some additional upside? That would be good for the client if the shares go up and also good for Jefferies and/or Cantor because they have the green shoe option To make them long at their net cost of $17.50-ish if they need it.
I have a CVS Part D Plan in CA and although I don't have a prescription for V I used the online lookup tool to determine that my copay would be $42+/90 day fill, but that's 5% of the plan cost while I'm in the extreme coverage part of the year. In Jan it will go back to Tier 4 pricing. At least no PA required.
My first thought when I read it was hey somebody’s been reading our board and TTE’s going to be pissed. I was reminded of North’s comment: it’s not who invents it it’s who records it.
Nevermind.
Now that’s pretty good free publicity. Somebody who worked at Amarin several years ago gets a new job and we get a detailed plug in the PR.
I'm 105% that has been asked and answered. The response time was 1 year and the company did not exercise their right to ask for an extension which would not have helped with so much time remaining in the trial.
When I saw the volume in the Jan $5 put my first thought was to look for similar numbers. The $21 strike is the best match. I speculate that a margin call could have been generated on the $21 short puts when the price fell and buying the 5's eliminated part of the risk and relieved the margin call. The $21's were sold for $4.15 so paying $0.11 for the relief is trivial. Certainly these trades were made by some very heavy hitters, and the strategy may be much more complex than I speculated.
The reality is that we can't deduce much if anything by looking at a single option trade.
If he really believed Dr Epanova was telling the truth, then TTE’s comment about MH is gonna lose his mind was too late.