Don't get your hopes up. For one, the % of the float short doesn't even come close to squeeze potential. Second, even on a positive ADCOM, smart shorts would just double down. This company has hovered between 2 and 3 dollars for so long, that even getting U.S. approval wouldn't multiply their revenues. On top of that they'll have a U.S. based competitor only a couple months behind. You need to see the forest and not just the tree. I do wish you the best though.
Look at ETRM for example. No love for medical device companies.
Overwhelming positive: $6
Borderline / Tie: $5
Remember, this is an ADCOM, not a PDUFA. Even a positive ADCOM does not mean approval. The FDA has already tore up the briefing docs.
Did EDAP provide a convincing briefing doc that the experts can say without question...
1) Is it as effective as current approved therapies?
2) Is it as safe as current approved therapies?
3) With everything provided, does the benefit outweigh the risk of current approved therapies?
I really think it's a decent product that is effective and safe. The only problem is, I don't trust the competence of EDAP management. Their briefing doc was horrible, the trial design was a joke and management has zero accountability or credibility. Otherwise, I'd be a buyer through ADCOM.
Just look at ACRX. All analysts predicted 90% chance of approval, but the shorts controlled almost 40% of the float. Guess who was right, the shorts or the supposed expert analysts? The shorts made their bet on an incompetent management team. See any similarities? I wouldn't touch EDAP with a 10 foot pole after reading the briefing docs. If EDAP is able to sell it to the ADCOM and they squeak out a positive benefit to risk vote, I would short all I could going into the FDA PDUFA. No way this gets approved, not without additional trials. They get a CRL for more information. I learned a valuable lesson with ACRX as I'm sure shareholders of GALT did today, if you can't trust management, GET OUT FAST! Management is just as important as the product. Unfortunately, I think most of us just look at the product and get burned by management. It's a no wonder why smart money started bailing on small cap bios a few months ago. I'm getting tired of this sector and am being a lot more selective. The momentum run-up days are long gone, it's become a caveat emptor sector anymore. On the bright side, if you do thorough DD, you can see where the smart money is going and from what I see it's into the high growth technology and restaurant IPOs. MBLY (Mobileye) just raised their IPO price from 17-19 to 21-23 displaying an already increased demand in the stock. They list Friday and I'll be a buyer as soon as it hits the market. It'll be the best IPO of the week. Watch for DSKY (iDreamSky) next week. They'll be a high flyer too. The question I asked myself is why take on the risk of these bios when I can dramatically reduce the risk without affecting the reward. Needless to say, easy answer. Just look at GPRO and LOCO the first 2 days of their trading and you'll see.
More half truths? If you read my posts, I stated I'm a trader and was selling in the morning. Also, I sold at almost the high in PM. LOL, what a dope!
Sierra is "for entertainment purposes only". She's nothing more than a hot lesbian with ZERO credibility.
You come at me with WebMD? Now I've seen it all. Maybe EDAP can use WebMD at the ADCOM too. Probably better than the garbage they gave the FDA.
Damn yoda, why you going through the briefing docs? If anything, you should've waited until tomorrow. The price should be lower.
And an ADCOM only 3 days away. No love for HALO?
The problem is this isn't an unmet medical need. A patient has about 7 different options, 1 of them being Cryo which is endorsed by the ACS over HIFU. Better bets out there IMO.
You mean EDAP? Yes, not good at all. It's now clear why management has kept shareholders in the dark.
Huh? You do know the study was HIFU vs. Cryo, right? You also know this is the study that they have left shareholders in the dark with, right? My advice would be for you to know what you're getting yourself into here. The 25% haircut and PT drop to 3.50 wasn't based on nothing. This ADCOM has become a crapshoot thanks to management. Red or Black? That's what it boils down to now. I see a negative vote on efficacy, positive vote on safety and a tie or close to it on benefit to risk ratio. Six months later, I see a CRL on PDUFA. Good luck!
The biggest challenge will be the cryo option. HIFU at least has to prove non-inferiority in efficacy and safety. If it can match cryo, the vote should go in favor. If it can't, it probably won't go in favor. Stock is really taking a beating though today. If it tanks all the way to mid 3's, you'd almost have to assume a negative adcom is priced in and it minimizes downside risk.
Be careful gloating, karma is a bltch.
It was a decent CC. The shorts are manipulating this down, which I had a feeling they would. I've learned never to underestimate the power of shorts in numbers. IMO it's way oversold. But also IMO, I think ACRX management screwed longs. They should've made an announcement that they filed an amended NDA with the FDA. That alone damages their credibility and trustworthiness. The product is fine, just need the right people to get it approved. Companies like this really tick me off to no end.
Well, I see the EDAP FDA briefing docs have been released and pps is dropping in PM as expected. I need to read them now. GLTA in ACRX.
But, being on thin ice I can't afford to hold out for better. It's the mess I got myself into and has absolutely nothing to do with the fundamentals here. I'm pretty sure it goes higher, but again it's a risk that I can't afford. If I wasn't in the position I am, I would've held out for more, possibly not even selling until tomorrow when some of the dust settles and the traders move on.
Although I don't care much for the high short interest in ACRX and I do have my doubts about management competency, ACRX will remain on my watch list for Round 2. I'll probably still listen to the CC and watch the tape (even though best practice is to move on and not look back, but IMO it's good to watch the tape for lessons learned) to see how this plays out, but I also have to re-focus onto EDAP and read the FDA briefing docs to make an entry there today. Briefing docs are always fun to read (sarcasm) and take several hours, all the while the tape is running.
Good luck in here guys, you'll be okay in the long run. For the investors, it's just a hiccup and shouldn't be anything more than that. My advice is to listen closely and hang on EVERY word during the CC. Listen to the tone of King's voice and see if it's confident or nervous. It's the little clues like that you have to pay attention to. Sometimes it's not what is said, but rather how it's said.
I hope you guys hit 9 or more today.