Is there any particular reason AVDL will pop once approved? CCXI and PTGX both practically doubled once approved (I believe PTGX was a hold that was lifted) but since then OYST, ETON, LQDA have all been approved and either not reacted or gone down.
So just wondering what makes AVDL more like CCXI and PTGX and less like OYST ETON LQDA etc
This is explained in the first post. There is no telling exactly what will happen once we hear the approval announcement, however we have an existing competing company (JAZZ) with a competing drug (Xyrem) that has an existing market cap, and we can deduce that a percentage of that market cap is associated with a drug that FT-218 will take over. That percentage is about 10x higher than AVDL’s current market cap. So the thought is that at some point it will approach that number, or JAZZ just buys them out for a portion of that number.
I was talking with a friend about the puts play after earnings, and he thought that I was probably “leveling myself”. Probably makes sense - if the stock is going to go up later, it doesn’t make that much sense for people that know that to dump now (although I guess algos or whatever got spooked by the FDA delay?). I’m going to try and slowly add to my long position again over the next few weeks. I still might try a couple of puts after approval, in case algos do respond to a preliminary injunction being filed.
I was burned by the initial AVDL FDA play where the FDA just didn’t give any news regarding approval. Given the crazy potential of the drug if approval ever comes, I kept the ticker on my watchlist to eventually play it again. Reading Yahoo finance comments, I stumbled upon this one:
In summary, it says that the FDA has a 10-month approval time limit to announce their decision, and that would place it around February 14th of this year. I have to say i’m absolutely not familiar with FDA approval timelines and protocols. Is there any truth to this statement that would make it worth taking lottos for march in case FDA approval drops in the coming weeks? I know a couple of people in the server still have their eye on AVDL, i’d be glad to hear your thoughts on this!
I think that was part of someone’s original thesis on this as well, that approval would likely be no later than that 10 month upper limit, otherwise that looks pretty bad for FDA. Not sure if any other drug approvals have blown past that 10 month upper limit before, without having actual changes or amendments to the application, does anyone know?
My understanding is that the FDA completed their initial review in March and accepted the new drug application on the 1st of March 2021 (date of the press release). Current FDA performance are that FDA intends to review and act on 90% of standard NDA within 10 months of the filing date. I believe we are past the 10 months.
Thank you! Might grab a couple of feb 18 lottos but I will limit my position to the bare minimum, the FDA seems to do as it pleases so I won’t act based on the 10-month decision rule
Have this on my watchlist as well-am starting a position for March and June calls. Seems like the FDA is starting to open up again slowly.
Based on DAK’s DD, and the product- if/when this is approved I assume we see good movement.
I wouldn’t be surprise if we see sell the news action after FDA approval by retail.
Me either- that’s why I want to start my position now. It got up to around 11 approaching FDA approval.
Think it could get back there- if you look at SENS it continues to go up based on their comments of approval soon.
Moved this back to main forum and out of archive based on FDA potentially picking back up on these drug approvals.
I grabbed two 7.5c for June.
The bid/ask is pretty wide but have a lot of time to adjust if need be. Think this will be a good starting position.
Might grab some March but feel like that might be too soon. They are presenting at a conference next week- so might get some more details around timing- I would expect some movement then.
AVDL just hired a Chief Medical Officer, probably a good sign of things moving: Avadel Pharmaceuticals Appoints Dr. Douglas Williamson as Chief Medical Officer
I will be meeting with them at DCAT in March. It’s an annual conference that “everyone who is anyone” in Pharma goes to. Last two years it was limited or outright cancelled because of COVID.
Hopefully they will have some updates to share there with the broader market.
But agree that this hire is bullish. Up again today- think we start to see this slowly climb as we move toward those March/June call strikes.
Going to start to look at March calls- been on a positive up trend this last week. Coupled with the news of the new hire and FDA opening up. Could see some continued momentum.
Eyeing 7.5s
This has been trending pretty well - are we still expecting good March momentum, or was this the run-up to some anticipated news that may make or break it?
They have earnings today- probably will get some sort of an update on the status.
My guess is something along the lines of “we are confident the FDA will approve, and have cooperated with their requests”
If they say “we expect approval soon” we may* see a SENS type situation where there is upward momentum.
Really not sure which way it will go.
I have shares and June calls.
***Yahoo finance may have lied to me about earnings being today- nothing posted on their site. Sorry about that!
On earningswhispers.com i can see Mar 22.
Yeah good call.
I assumed they will try and push earnings as much as possible until they get word from the FDA.
They are presenting at a Sleep study conference next week- probably won’t do much by way of movement.
But think we hear something before Summer one way or another.
