The Tommie poster has half the answer.
Yakatan and the Reign of Error was truly ugly.
The other half is wrong. A preprogrammed stock sale is no big deal - in fact nothing other than a preprogrammed stock sale that had been approved by corporate counsel and industry practice would be saving his ass right now.
The stock sales are a smoke screen. Katkin can make a valid argument for being an honest actor. This submission is in a league by itself - in fact Yakatan's submission now looks like some henscratching on the back of a napkin.
If I were you I would't poo-poo manipulation. If there is any doubt in your mind go find the Dendreon story (15 sordid chapters on www.deepcapture.com) and then bear in mind that the majority of all of the bad actors mentioned regarding Dendreon are here in AVNR in a big way.
Putting it bluntly - You sir are in Shark Infested Waters with the rest of us. Ever read the WW2 story about the Indianapolis and the Battle of Coral Sea??? That is what I mean.
The toxic and corrupt history of the Avnair's management team that was reaffirmed by the sneaky Katlin dumping shares a day before diluting the baggies.....it clearly illustrated that this punk is no different than that other creep: Boy Blunder......
I did something akin to that analysis before I bought more today.
If prospects are so good why the price drop?
1. "Sterile news environment" prior to approval...if that's all it is then this is a great time to buy. All the other "great" buys out there in this market mean this will see a steady rise through Oct.
2. Overall market in the dumps...that plays into it but also means this is one of the few bright lights
3. Missing something big?...I don't think so but I'm always reexamining
4. Manipulation...I usually consider this the realm of conspiracy theorists and hate to jump on that bandwagon. However, there's enough out there to give it some credence.
5. Safety concerns...overblown by the bashers for sure. Market could get reduced if FDA requires harsh warning language but I don't see it.
6. Market capture...gotta like a receptive audience with no competition
What did I miss?
Regarding the current market drop?
Well start at 2.75 or so because that is what we sold at, then factor in a shitty market and a sterile news environment for the next 4 months.
Or better: turn all o fthis stuff off and come back in September.
Speaking of 18%- look at slide 8. That includes the less than "moderate to severe" pba potential patients. Higher number there of the overall 18-20mm with underlying. Point made was that this additional 8% could also seek treatment.
I'll answer that
Look at p 30
All Cause Discontinuations was 26-28% with 30/30. It is 8.2% with 30/10. Our market just grew by 18%.
18% of 2,000,000 patients is 360,000 patients. Theoretically, these are patients we already know about; and now they don't have to quit using our drug.
I'm fired up
Listen to the Call then read this again.
Really when you stop and think about it...
How many drugs that are generally regarded as safe and effective get rejected? Anyone care to do the research on that? From my anectdotal observation, most 'failed' compounds get nixed in the earlier stages; ph II/III trial failures to meet end point targets, serious adverse events, etc. These are stopped by the company long before they reach the FDA.
Now, compare and contrast with those drugs that get outright rejections once completing their final PH III trials. Perhaps someone with the time and inclination will take a look for some. Now add to the mix drugs that get sent back with approvable letters- now formally known as complete response letters- CRL's. Were these bad drugs that the FDA wanted to keep off the shelf?
Or rather were they presented with insufficient and/or sloppy data packages that left the FDA investigators with doubts to be addressed?
Knowing the history of AVP-923/Neurodex/Zenvia, it's my belief this falls into that latter category. The trials were never interrupted by Avanir, their clinical investigators, nor the FDA. We've heard no horror stories of adverse patient responses- and in that vein- of the numerous and oft-mentioned legal actions filed against Avanir, not a single one was brought by a trial subject. Generally safe? I think yes.
Now let's look at the historic debacle of the Zenvia NDA. Yakatan wanting to line his pockets by rushing the filing.. rolling review bs, priority review premature pronouncement, etc. Fast forward to the late entry of the Thorough QT study- which was being done for the DPN indication at the time. Fast forward further to these other pre-clinical additions that are now part of the data package presented in response on 4/30. Add to that the extra patient-years afforded by the STAR trial and more comprehensive safety and efficacy data with the reduced Q formulation.
Forget all the noise for a minute. Take the stock manipulation and shady management out of the equation for a second. When you really stop and think about this- ask yourself- why would the FDA be inclined to reject Zenvia now? Versus, would the FDA approve for market in light of all, upon evaluating this drug before them, one that is first in class addressing an unmet medical need (Priority review still intact). One that was 'approvable' before re-issued with scads more hard data to review now. Weighing the risk/benefit, when you really stop and think about it, that is all that one really needs to decide.
What did today's call do for your opinion in regards to chances for approval? Better/Worse/Same? Good luck to us longs.
good overall presentation...but I'm still concern about the pps...I understand that we are being drag down by the overall market condition...but what I cannot understand, looking at it from a technical perspective, there is no support in the $2+ range, which will present a free fall back to the high $1....and to me this is very bad.....every buy is met with huge blocks sells...this is very worrysome!