just to be fair....
I like how you have "inside info" about some sunday article.
just like there are longs that lie there are shorts that lie.
And it's not even a convincing lie.
Can i please offer advice to the DMD community without people here beating me up for it?
It is a simple idea but not necessarily easy to accomplish, but I think it would help.
Ask your DMD doctor to proof the letter and offer suggestions as to how to make the points stronger and refine it further to address the FDA's response.
that is all. I didn't say it would be easy to get a doctor to do. But I think if you guys are going to write letters, pass them all by your DMD doctors first.
However, this sideways action threatens to break the uptrend.
longs need to hope for no more sideways action from here, but more buying up beyond the 15.5x range and into the 15.6x range and higher.
We who are holding short are liking the sideways action and hope that 15.47-15.51 area that has been hit 3x so far is a "triple top" and will represent a breakdown and decline in price.
Time Will Tell.
Just trying to give a taste of day trading.
last quarter, excluding the sale of stock, they ran through over 21 million, but skip 2 quarters and look at the next and they ran through about 7.5mil. Over the intervening 2 their burn rate was well enough over 10mil that 10 mil is a kind estimate.
So, that is one whopper not told.
you mean like -- "The FDA Loves These Kids"
"performed 1000x better than expected"
"kids were running around like kids"
please point out to me where my "whoppers" are.
you make good points
that cost analysis may be done, may not. It depends upon the size of the phase III as compared to the patient population. If the two numbers are close enough it may be cost effective to move it from an expensive lab synthesis process to a contract manufacturer.
someone out there choose buy or sell and do it hard. I'm trying to justify my continued monitoring of it today.
I am debating the full scale ramp up part.
The path to approval is phase III.
Phase III involve MANY more patients than a phase II, AND in fact one of the FDA criticisms is that the dataset was too small (not enough patients in the trial).
So, depending upon how large the phase III, the patient population in that trial could be on the order of magnitude of the whole exon 51 DMD population.
So, it may be wise to continue with CMC and find a contract manufacturer or a minimum do a cost analysis to see if they need to take the synthesis of eteplirsen out of the lab and into production.
But that doesn't fully address the original questions, in particular the second one:
available to the m#$%$es? Considering the guidance, they need a phase III per the FDA. SRPTs belief is that it is functional so it is up to SRPT to continue with CMC right now or focus on phase III and keep making it in the lab....
but the m#$%$es? That means FDA approval. Best Case is 3 1/2 to 4 years from now for expedited (not accelerated. expedited only take 4 months off the normal process) before anyone hears the FDA decision on a NDA (new drug application) ... and that #$%$-u-me's the FDA takes the phase III results at 96weeks of that phase III study.
as far as efficacy testing... square 1.
They have passed phase I, phase II was inadequate, but the good news is the FDA will take a look at a phase III... if SRPT can work the the FDA and vice versa to properly design the tests.
well how any times was I told I was stupid when he stock was rushing through the $50 level and going to $55?
You can't compare PCLN or even AMZN or even TSLA to this.
Did any of hem just have their best of hope of real revenues & future profits get totally shot down by the FDA and any 50-50 hope that is left pushed out 3 1/2 to 4 years.
This is dead money for that time. none of those others mentioned have near zero revenues & no product being sold for years to come. Further their cash burn rate will necessarily increase, a point TOTALLY missed by the Barron's analyst. You can't have 10mil cash burn each quarter for the past year ,then expect 10mil cash burn with a phase III study of 50x to 200x the size of the phase II population. The drug costs SRPT money & cannot be sold during the phase III. Additional testing & testing design & analysis wilL all cost more money. Plus, it's typical to expect costs to, if not set up manufacturing themselves, pay a contract manufacturer up front payments to get things started. None of this was factored into that barron's analysts statement that "cash will last..." It's totally obvious that they have just enough to cover until then but at the current rate, AND because costs will increase.... that means either a secondary or losing a portion of future profits to partner with big pharma. That costs more cash burn.
Range? here 12-18? maybe 9-12 in the near term. Why? This thing needs to be priced at where it was BEFORE all the anticipation of preliminary results, because the FDA just threw all of that out.
Bad news for this patient...
SRPT is back to being a mere startup drug company with a hopeful target molecule identified and synthesized. That is all. The FDA considers all that "meeting end points ad X weeks" talk just unscientific, proof-of-nothing numbers.
SRPT is back at square 2 or 3, (certainly they are further than sqaure 1 since they have eteplirsen to test)... but as far as testing: square 1.
oh, and "possible buyout news" ... I can only call it garbage... is exactly why posts like this gets called pumping in the derogatory sense if there is any other.
Well, here you are... pro-SRPT and anti-FDA decisions and a firm believer in SRPT.
Why would someone with a firm belief in eteplirsen and SRPT think a buyout would even be necessary?
because of the evil FDA? At this point even big pharma cannot be expected to go to the FDA with the 96 weeks dataset and say "change your mind." That is ridiculous and you cannot be so ridiculous.
My only conclusion is that this is just an effort to keep pumping up the share price.
I see this as
1) a pop off Barron's
2) day trading feeding.
Since short shares are easy to come by now, I've actually considered switching from shor to long today and then switch back to short jst to ide this wave. Unfortunately, as mentioned, if you are not in on the momentum before it is a play, then it is very dangerous to play it. So, I've just held short.
In fact, I also played a short day trade too from thefirst intraday overboght area of low 15s to high 14s. Made a bit of the money I'm losing on paper back. It was looking ripe to pick short again at mid 15s earlier but I passed on the 2nd day trade chance. I didn't feel comfortable within myself. You get a bit of a "pat on the back" syndrome after a quick trade. If that feeling hasn't worn off then you risk being reckless or sloppy and blowing the next trade.
be very very careful buying momentum spikes like this.
it is like musical chairs. when the momentum stops you do not know if you will be burned and be buying the top or near the top and looking at a sttep drop.
Here are two extreme recent cases of momentum runs over the last 6 months that occurred twice... TWICE! in the last six months.
Fannie Mae and Freddie Mac.
Boring stocks right?
FNMA and FMCC over 6 months.
INSANITY on the price action.
and if you bought friday, you are feeling the pain today.
These are great gravy trains for all that are in them early, but once that momentum gravy train has left the station -- DO NOT TRY TO GET ON!
predict what time and day that momentum stops and it plummets. Impossible. And all it takes is another more attractive play once the momentum crowd thinks the curent one is played out. Or some bad news? Or just a crushing realization it is over priced.
But there is talk of efficient market theory and the market sets the price, so that must be the fair price. Well, when it changes direction just because and loses in a plunge as fast as it came -- well, you must know that I think markets are not always rational nor efficient.
This jump will play out... but when you are guessing the top... keep in mind it is a TOTALLY wild #$%$ guess.
Even my hopes of it seeing the 16s is a hope based solely on where the market opened tuesday and that maybe the market will take it to the high 16 or low 17 dollar level again before the truth sets in.
Who knows... if the momentum players get ahold of if real hard, like a pit bull, maybe it pulls a FNMA. You just never know.
Be Careful. Very Careful.
I did not want to post this but I will hedge my answer.
I did NOT check all the recent institutional holders, ok?
My newsfeed shows that only Viking Global Investors LP had a disclosure change.
That disclosure (SEC 13F filing) and the previous one can be seen on the SEC's edgar.
It will be required for you to look at the most recent and the previous to verify this information.
Their 8-14-2013 filing shows 668,175 shares
Their 11-14-2013 filing shows no entry. which corroborates my newsfeed which said Viking Global Investors sold all of their position.
Good news, bad news
**Good: there were no other sellers in my newsfeed
**Bad: there were no purchasers in my newsfeed.
Don't shoot the newsfeed reader. Instead, go online and search this info out yourself and verify it.
If you guys could get it up into the 16s again I'd be really grateful....
3.5 to 4 years from now AT BEST will be the day the drug is evaluated.
the arm chair FDA analysts here will not do it. Why? Well, the FDA's recen rejection sure caught the pro-accelearted crowd off guard. Been wrong once, and I'm waiting on the FDA's opinion! The FDA will be the one who approves it or shoots it down.
I wilI am waitingg for signs this bump is played out like that bump from 30s to the 50s then back to 30s played out.
It took longer than I thought to play out, but it played out.
This bump will not last.
3.5 year to 4 years of reality will set in soon
Cash burn will set in soon.
Yet another secondary will set in soon.
The fact SRPT blew the testing for BOTH the 6MWT ... AND the dystrophin points.
The fact that this is now back to a coin flip of 50-50 will set in again.
I'll be patient. I have my order set up waiting to enter every day.
PS I am already short, and am waiting to short more.
This weekend even the people who are AGAINST the FDA's decision were talking about dystrophin production and how the idea is that this won't cure them nor will is cause their muscles to regenerate.
Well, that leaves an elephant in the room. SRPT submitted data with 2 kids who showed improvement.
This is with a dystrophin molecule that is supposedly more like dystrophin's shorter sibling. Further production was not at 100% levels, so even if it were to somehow work to regenerate how could it really regenerate if production levels are significantly below 100% of normal levels?
And it is tempting to say "eteplirsen, duh"
but how do you then explain that the dystrophin molecule production isn't up to normal levels and people didn't really go into the esting even expecing improvements... it was more like slowing the erosion hopefully to nil... and certainly not rebuilding.
show me, prove it to the FDA.
(I have a possible explanation in mind I will reveal later)