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Thanks again Dew.
According to google, this fall starts 9/23/19.
I would think we will know earlier than that.
Thanks Dew,
In the first slide, it stated BOTOX Biosimilar update summer 2019?
Summer is about to be over .
If the stock price was $18 when AMRN announced the secondary, the stock price most likely will be under $15 now.
It is the future earning that is attracting the current valuation with certain level of risk/discount built in.
I think the 2020 revenue should close to $1B if not more (assume label expansion is approved) as 2019 2Q revenue is almost 90% more than same time one year ago without the label.
Do you have the source of this information?
TerryPharma on twitter also twitted this.
Thanks
Agree with this.
I think the pre-announcement of 2Q revenue along with SP gain is to set up for this secondary offer.
The following is from 2Q 19 earning call transcript:
"As a reminder, it is traditional that label negotiations commence relatively late in the FDA review process. Often such negotiations are the focus during the last month of review. A final label is not available at this time. It would be unproductive for Amarin to speculate on the wording of such a label before a final determination on the sNDA."
Am I reading too much to think AMRN already start label negotiations with FDA?
With the sentiment on this board last a few days, I would think majority of the people is worried about FDA may not approve label expansion.
If sNDA approval is a high probability event, this raise will not be much of an effect after the approval.
My sense is most people start to worry approval may not be a sure thing as why not wait until the approval to do the raise if the company thinks approval is highly likely.
Thanks for these polls on Twitter.
I am not sure if I have seen a poll about sNDA approval.
At this point, sNDA approval or not would be very important to the share price.
If sNDA is approved, this raise would be forgotten in no time.
An expanded label on or before PDUFA date should fix this.
Well reasoned post.
I think at this time the key event/risk is still FDA approval sNDA.
What is the chance that you think this may not go smoothly when PDUFA comes?
Maybe someone is expecting the stock to make a big move next week after earnings .
It is about time.
Well, I still believe the key is to get the sNDA approval with a reasonable label.
Once this is done, GIA or a BO will both do all longs well over a reasonable period of time.
So I still think the biggest risk is still with FDA.
The option is kind weird for Aug.
With stock at 12 & change, the bid for $15 call is $0.30.
I am pretty sure ICER report has no impact to FDA approval decision one way or the other.
THe company guided on 7/2/19 that 2Q revenue is between $97m to $101m.
If conservative is the hallmark of AMRN, I will say the revenue should be at least $100M.
Also if the merge may affect the decision one way or the other.
Is it legal to sell prescription drug on eBay?
Maybe with a pharma license.
This topic has been discussed extensively on this board.
Just look back the history of the posts (not too far back) by DD & others.
https://www.wsj.com/articles/pfizer-nears-deal-to-combine-off-patent-drug-business-with-mylan-11564228743?mod=djemalertNEWS
This may delay mylan decision on Botox biosimilar.
The volume of this drift down from last week is less than average (close to average).
RVNC was close above $13 one time last week.
It shows how quick the stock can move, usually always towards the downside .
This type of move seems happening to quite a few biotechs without near term news (or without news for a while).
Mylan Botox biosimilar option is a wild card near term.
It could go both ways. If Mylan opted in, it should give little boost.
I think we may be surprised to have an approval before 9/28/19.
It is relatively common that sNDA may be approved before PDUFA date.
This is from twitter.
First time I can recall ICER showing a drug is significantly underpriced based on cost benefit $amrn https://t.co/6a3N7JAhqh
— Peter Suzman (@Biomaven) July 24, 2019
Is DEXTENZA currently only targeting medicare patients, as there is no private insurance company will reimburse the cost?
Your analysis is logical. But I think an extension of PDUFA date is a low probability event as FDA can simply grant a standard review when FDA accepted the sNDA application.
By granting a priority review & then extend the PDUFA date is not very logical thing to do by FDA.
A partnership announcement for Vk5211 would be nice.
Would love to see someone comes in do a deal similar to GILD & GLPG .
I think they need this new open label trial to get 300 patients for at least 6 month & use the STRIDE-1 trial to get 100 patients for at least 1 year.
STRIDE-1 design is to have 125 patients on AXS-05 & 125 on Bupropion.
One question is: are patients in the trial on the drug continue dose after 6 weeks over or they stop dose?
Second question is: can AXSM combine this open label trial & STRIDE-1 to get to total of 300 to satisfy safety requirement?
Thanks.
This is the exact line in TDAmeritrade:
July 11, 2019
7:51 am ET
*Axsome Therapeutics Says Is Enrolling Two Open-Label Studied To Build Safety Databases Of Patients To Support The Filing Of A New Drug Application For AXS-05 In The Treatment Of Major Depressive Disorder Amd ASX-05 In MIgraine
Benzinga"
So looks like they quote Benzinga as the source.
TDAmeritrade has a headline news about Axsome starting two open label studies to build Safety Database to support filing of NDA for AXS-05 for MDD & Migraine.
First, I cannot find any details on this. Second, AXS-05 is not in any Migraine trial.
Anyone else see this?
Thanks
Thanks Kiwi
Pretty logical argument in this new article.
https://seekingalpha.com/article/4272245-axsome-therapeutics-adds-another-catalyst?dr=1#alt1
The volume last Friday & today are higher than normal.
AXS-05 Phase 3 for MDD should start any time now as the company guided it will start 2Q19.
I think AXS-05 is the key.
If TRD P3 results are good, it can go up very quickly.
MDD is relatively de-risked with P2 results.
For me 07 & 12 may not increase much of the value even with positive reading, but if negative, will bring the SP down.
AXSM seems has a habit of not being keep their promises when come to reporting trial topline data .
AXS-05 p3 for TRD at least delayed twice.
I was waiting to for AXS-12 topline data before i buying more as I would like not to have to wait for a shoe-drop.