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"the calls bought are all near term and around 16 and based on the cost leading to a 2-5 dollar move expected with any news"
Maybe someone is buying a bunch of shares. They buy calls ahead of their purchase & the gains from the calls reduce their cost of the shares.
The CITI replay is available now.
Can you imagine investor reaction if AMRN had given notice of the ADCOM at this late stage? It may have put a few people in the ER.
I think JT was forced to announce the FDA's intentions of an ADCOM since management had started to give investors the impression there wouldn't be an ADCOM due to the number of weeks before approval & statements that the FDA had not given them notice of an ADCOM.
Its looks bad on the FDA if they miss deadlines for PDUFA's so they issue CRL's in most instances. In this case they can extend the PDUFA in order to conduct an Adcom without impacting their PDUFA timeline goals.
I'm not sure you can call it BS when the company released a PR stating they anticipated an extension with a new PDUFA date for late December.
"How many people posted about using that short against the box as a tax strategy until you came along and debunked it with the facts? New poster Lar (?) said something about being surprised about this board not allowing misinformation (intentional or not) to go unchallenged - this is a perfect example of why it's necessary."
He didn't debunk anything
You can still short against the box & achieve tax deferral on an open short against the box position at year-end if you buy to cover the open short position by Jan. 30.
I'd rather get notice of a delay due to an Adcom then a CRL. I don't see the lack of a Adcom notice as a good thing.
I could swear that I originally invested in this stock since I thought it was low risk. Its tough to be this wrong when the companies never really reported negative news on the pipeline.
Think about it. It would be crazy for funds to have gains in AMRN without using some sort of hedging strategy. As AMRN's stock falls an algorithm guides them to short a percentage of their holding in order to protect their investment. This is why your seeing the short increase keep increasing as the stock moves lower. Some of the funds can't sell on the open market like you can since they have to file a Form 4.
The short interest numbers mean ZERO. Have any of you ever heard of shorting against the box? Some of these funds have huge long-term capital gains & they short the stock to lock in the gain without triggering a taxable event.
What doesn't make sense is for AMRN to announce that the FDA plans to conduct an Adcom & for there to be this long of a delay in the formal filing.
I'm not scared. I said the chart is scary. I used to buy stocks when I considered them oversold or undervalued without looking at the chart. I've learned that you can't ignore the chart. Just because its cheap doesn't mean its can't get a lot cheaper in a market like this.
I'd like to add some shares but you're getting in front of a freight train at this point. The chart is scary.
I don't know why people are making it so difficult. AMRN has anticipated an ADCOM from the very beginning. yea, we got screwed since this is going to create a delay but that's just how the FDA works.
Vascepa's market is tens millions & may change the standard of treatment. It makes perfect sense to have a public discussion on the safety, MOA, label, & possible mineral oil interactions.
The FDA would be lacking if they didn't conduct an ADCOM.
I originally was going for a high quality pill with low DHA but I guess my next step should be a EPA only supplement. I see that Amazon sells EPA only supplements & that's what I'll have to use until AMRN gets the expanded label.
I've taken an over-the-counter fish oil for the last year. 2200 mg - 1400 EPA, 480 DHA.
My triglycerides have gone from 214 - 131. I'm not taking any other lipid meds & none of my other numbers reduced significantly over the last year so I'm tempted to say the OTC is working.
Cholesterol - 250 - 226
HDL - 38 -34
LDL - 169 - 165
Non-HDL 212 - 192
I'm going to have to add a statin but I've been telling my doc that I'd do diet & exercise first which isn't working. My OTC only costs $37.86 for a 3 month supply so there is no way I'd pay $240 a month for Vascepa.
I don't understand why the FDA would ask management to hold off on notifying the public prior to the ADCOM registration. What good could possibly come from delaying the announcement? The whole thing doesn't make sense.
The market reaction to the Adcom is ridiculous. The FDA has to cover their ass if they're going to grant Vaspeca an expanded label. Yea, they screwed them by delaying the application but its not abnormal when a company & the FDA are negotiating on something this big.
That's what kills me. It will cost AMRN tens of millions in real dollars & opportunity costs to delay an approval 3 months since they can't convene a panel in time. The FDA could care less how much their delays cost companies & then the public wonders why drug prices are so high.
How hard did the FDA work to set up a panel would be my biggest question & why couldn't they do it sooner?
I'll wait to add when they release the briefing docs. I doubt this is the bottom.
I was trying to figure out the large call buying in Mylan. I guess you just provided the answer.
That would be good news as far as I'm concerned. Never understood why we wanted to compete with ourselves.
I seriously doubt it. I think the only way to change investors perceptions is blow out data from the cervical dystonia trial. I'm pretty much ignoring the stock until Oct/2020 & looking for 20 weeks duration & a good safety profile.
"What do you see the upside being in the next 6-12 months"
I'm not looking for any partnership announcements. I sort of think we'll trade with EOLS. If they do well then I think our stock price will also move up but if they struggle gaining market share then we'll stay in this range.
"is this a good investment until then", I wish I had the answer.
I'd love to know what managements thinking is on cash. They have 7 quarters of cash which takes them thru 2020 when they'll be on fumes. I'm thinking DAXI's possible approval won't be until Sept/2020 so do you risk an approval delay before raising additional funds?
I just see us limping along until the company can prove itself with Phase III data in the therapeutic setting or a strong aesthetics launch.
I've had a good year & will do some tax selling so I'm wondering if others will do the same & it will continue to pressure the stock.
I'm betting the companies not bought out until they can report positive data for Cervical Dystonia which is probably Dec/2021 at the earliest.
Sell every pop has been the winning trade for months. I thought we were going to have a good day when we were up over .50.
Revance Therapeutics, Inc. announced the appointment of Jill Beraud to the company’s Board of Directors. Ms. Beraud brings more than 25 years’ experience building luxury, fashion, beauty, and consumer brands. Ms. Beraud will also chair a newly-formed Revance Brand Strategy Committee focused on establishing the company’s innovative neuromodulator, DaxibotulinumtoxinA for Injection (DAXI), in the minds of consumers.
Its as good a reason as any for RVNC to trade down.
SLNO - I took a position in SLNO earlier in the year & booked a 150% gain when the Data Safety Monitoring Board recommended to continue the trial. One of my luckiest trades since the stock gave back most of those gains at the End of the Day. I re-entered the stock & wouldn't be surprised to see a 100% gain when they announce completion of trial enrollment.
DCCR has a good safety history & the slow release formulation should reduce side effects. The numbers are small but Slide 12 of their investor presentation seems to indicate a positive drug effect. The Phase III has a low bar since they only need to show a reduced incidence of hyperphagia & the stock should skyrocket. I like the risk vs reward & I'm working with free money so I'm riding some shares to the end.
http://investors.soleno.life/static-files/1868bef5-4609-4435-8df4-e9a927f2f1dd
I added shares for the first time in probably a year. I'm counting on the "anything is possible" theme.
I was in MNTA & took a bath on that one also. If a buy-out was in the works then it makes sense they didn't raise enough cash to fund the current trials. Now that a buy-out didn't occur the market is punishing them with each secondary.
RVNC should put a Kardashian on their board of directors. I'm not sure the FDA would like it but investors would.
Good article on the Cancun trip & EOLS launch.
https://www.fiercepharma.com/pharma/cancun-beach-bash-evolus-invites-experts-to-meeting-ahead-jeaveau-launch
EOLS trading down today so that seems like a good reason to sell RVNC also.
I only saw one significant new holder from the 13F filings but I also didn't see any significant sellers in RVNC last qtr.
BAMCO 500K shares.
A competitor to Botox -- Jeuveau -- courted plastic surgeons with a lavish trip to the Ritz Carlton in Cancun. The doctors' promotional Instagram posts may have violated F.T.C. rules.
You have to be a subscriber to New York Times for full article.
https://www.nytimes.com/2019/05/15/health/evolus-wrinkles-toxin-jeuveau.html?smtyp=cur&smid=tw-nythealth
I don't understand why they wouldn't file with the smaller vial & then file a supplement for the 100 unit vial. You don't need a 100 unit vial for glabellar lines.
Whats the reason for the BLA delay? I couldn't force myself to listen to the call?
Thanks for posting IR's response. Does anyone really think an announcement regarding a clinical pathway for Mylan is an important catalyst. If Mylan was smart that would have bought out RVNC instead of signing the biosimiliar agreement.
Filing the BLA is what want to see.
"They have made their case, its up to others to either buy it or pass"
You answered it. They haven't made a good enough case as indicated by the lack of buying interest.
They haven't attracted strong enough funds that will support the share price.