What do you derive more enjoyment from? Investors losing massive amounts; investors who will no longer fund critical research - causing many medications to never be found & countless people dying because of it; or the kids with DMD who will now die needlessly?
So IF the adcom votes to approve Eteplirsen, does the stock go back to $30/share?
If the briefing documents weren't so "harsh", let's pretend neutral and we stayed at $30, then the stock would shoot to $60 on approval or higher.
However, now with the 50% crushing blow today, upon approval it will be lucky to get back to even.
Market manipulation? Is this a classic example of how to keep an otherwise rocket stock from going up?
SRPT apparently got some rough FDA briefing documents ahead of their adcom next week. Apparently the market thinks they aren't going to get approved. PTCT down because apparently the FDA wants all these little kids to die.
Voted down BMRN, seem ready to vote down SRPT, and therefore, what hope does PTCT have with such a corrupt FDA?
I'm so incredibly disappointed that IR was so unbelievably non-responsive, and that management blew through the deadline without so much as an update. Yes they did get the NDA filed finally, but Wall Street appears to have punished this company for their lack of communication.
Makes me really nervous about things going forward.
So you are happy that so many people are losing money, and life saving medicine still isn't approved?
Speaks volumes about you.
Only a complete iddiot drives by looking in the rear view mirror.
I'm interested in the FUTURE. I want to know what projected sales are. That is what I said. PROJECTED. If the total patient population is 6,000 I'd like to know that. If 300 then I'd like to know that. It changes the equations.
EMA has already conditionally approved it and they already have paying patients. Why are you in such denial? What are you afraid of?
Whole Biotech sector is getting hit hard today.
I don't see any relief in sight as this whole market is awful.
Why be such a JERK?
The math is easy if you will stop long enough to look. If you don't agree with the numbers then that is fine, this is just MY estimate. You're agreement is not required.
206 patients on the medicine right now. $500K annually (conservative, because US prices are supposed to be $700K per patient per year and most patients are in the US) takes us to $103M/year, though I rounded down to $100M/year.
Looking at the worldwide potential patient population of more than 6,000 across the first 3 uses of Ataluren (remember, they are targeting 10 disease situations to use it, I'm only looking at the first 3), again we come out conservatively at $3B/year.
Price per patient in Germany is $500K annually. $700K/year in U.S.
From press release:
Completed a landmark first year ex-U.S. launch of Translarna™ (ataluren) with 206 nonsense mutation Duchenne muscular dystrophy (nmDMD) patients on commercial therapy as of January 8th, including patients from both commercial sales and reimbursed early access programs.
Translarna is now available on a commercial basis in 18 countries and PTC has a global commercial footprint of 46 countries either directly or through commercial partners.
Preparations are underway for a potential 2016 launch of Translarna for nmDMD in the U.S.
Completed rolling NDA submission for Translarna to FDA and submitted Phase 3 ACT DMD results to EMA fulfilling the principal condition of the approval in the EU. Regulatory decisions are expected mid-2016.
Following the submission of a variation for Translarna for nonsense mutation cystic fibrosis to the EMA in 2015, PTC is responding to questions and expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) in mid-2016.
I blame IR who didn't say anything whatsoever as the deadline passed. No indication it was imminent, no response to any of the contact attempts via their website, just nothing but stone-walling. Wall Street doesn't appreciate firms that ignore investors.
As it stands, there is so much bad news saturating the market that no good news matters right now.
Agreed. It could be because they did miss the deadline without any information from the company about it. No message saying to standby it is imminent, or anything at all. The market is extremely intolerant of a non-responsive Investor Relations (IR) department.
It also could be that the good news is simply overwhelmed by all the bad news in the market. Had this happened on schedule the last week of December, we would have seen at least a $10 bump upward.
So done. Not sure if they made the EOY as promised, but at least it is filed with the FDA. This really should be a powerful catalyst upward, even in this dismal market.
So they may have filed on time after all, just didn't release the news yet.
This may get very interesting very fast...
Looks good on the new P1 trials they started.
On the Ataluren front, I guess they are waiting for the FDA.
I saw a pump piece on CNBC and boy were they wrong. This company is nothing more than a sham. They might have a product, but looks like only for Android. They are going to be pushed out and left far behind because they can't get their act together & can't get it in gear.
Agreed. That will be the triggering event that smashes through the $35 resistance barrier.
MUST have the NDA. Crickets from IR. Hope they are saving a ton of $ on IR, because they are useless.
Lists PTCT as one of the top 5 stocks to buy. Once it breaks through $35 resistance level, shoots upward hard and fast.
With the FED raising rates without reason (no inflation) and oil still on the basement level, BioTechs are one of the few (only?) hopes for profits in stocks this year. Watch for money to stream in during the 1st quarter.