AF believes the FDA could be waiting on biopsies. I vaguely recall that the treatment wing is fully enrolled. Can anyone substantiate that? How long ago did that happen? I just can't remember, as I've been tuning out the noise the last several months. Also, the clinical trial mentions biopsies at 12, 24, 36, and 48. Do I assume correctly, that each boy will be randomly assigned to have a biopsy at one of those time periods.
I believe that a fair number of boys are well beyond 48 weeks. Correct?
Trying to figure out when the biopsy data will all be in.
Here's a thesis. I'd like your opinion. Adam always has access to smart, institutional shorts. For the first time, he has admitted that none of the smart, institutional shorts he contacted were actually short Sarepta. Could it be that the new short crowd--who, significantly, took their short positions immediately before a massive run-up in the stock--consists of dumb, noninstitutional money?
Simp, what are you seeing in the option activity? When I click on the options here on Yahoo, I'm not seeing much. Is it missing some volume?
While we're at it, did anyone ever post the January 18, 2016 article about Andrew Nichols from the Newark Advocate? He's had an exceptionally bad time with the disease, unable to lift his arms after the age of 7 and limited to a power wheelchair at all times. He started eteplirsen in April. For the rest, I will quote the article directly:
As the treatments continued, Mitch and Jodi were amazed when their son began doing things they feared they'd never see again.
Andrew began crawling and raising his arms above his head. When he dropped something, he was able to reach down from his chair and pick it up.
His parents were amazed when he started walking on his tip-toes in a hotel pool, without any assistance.
When they went to King's Island, Mitch didn't have hold Andrew up when they rode the roller coasters.
Those may seem like small things, but for Andrew and his parents, they were huge accomplishments.
"There seems to be an endless list of things he can do," Jodi said. "And he feels better. You can just tell he feels better."
It's hard to say whether Andrew will ever be able to walk again, but the drug is helping his body bypass the missing part of his X chromosome so his body can start building some muscle, Jodi said.
Is it possible that what has made the company insiders so bullish is that the company is learning that exon-skipping has a much stronger and more immediate effect in the "easier" exons, such as exon 45?
Read the following tweets. This is totally unlike the experience with exon-51 etep, which we've now read many times is the most difficult exon. This is insane:
back on Jan 29 Tina Graziano Carson tweeted:
Tina Carson @TinaGrazianoCar Jan 29
My 15 y/o long term PT sessions = w/c bound
Billy @ 15 #etep kid = fully ambulatory
Then on March 18:
Open Label Week #1 🍀💚
$SRPT #exonskipping #45
Then on Mar 22:
Pool shenanigans! Took video of my son's ability to swim before receiving first dose of Sarepta drug.
Then on March 29:
Best swim in years... 4 laps (2 w/without a noodle).
Then on April 1:
Tina Carson @TinaGrazianoCar 12h12 hours ago
Trying to make sense of all of this.... 12 laps in the pool today ..... 6 w/without a noodle.
#Srpt #exonskipping #45nonambulatory #Adcom
It is possible that some of the anonymous posters below are declaring that the recent insider buys and decisions to accept options over cash are based on nothing more than confidence in order to diffuse accusations. However, the very suggestion that directors and officers do not know anything more than the public is laughable. Insiders are BY DEFINITION individuals with access to non-public information. They have non-public information every day. Every hour of every day they learn a little bit more that the rest of us. If they didn't have non-public information, they wouldn't be doing their jobs.
Now let's consider the public information they allegedly based their trades on:
1. It doesn't matter one whit how strong you or I think the data is. We could draw charts about 6mwt all day. We can write pretty arguments about dystrophin and Becker's and all the rest. Doesn't matter. Only the FDA's opinion matters.
2. The FDA has publicly commented on SRPT's data exactly one time--in the briefing documents. In these, the FDA heaped unrelenting scorn on the data. Not one ray of sunshine emerged from those documents. Not one line permitted even the slightest trace of optimism. Those documents were a black hole with an irresistible gravitational force sucking in all hope. There was absolutely no room for even the most delusional investor to have any confidence based on these documents...
3. ...And yet the insiders have all made a big bet on SRPT just before the FDA meetings.
Folks, I don't care whether you consider it legal or not. Heck, I don't care if it IS legal or not. I just don't care. The only thing that matters is those trades would never, ever have been made based on publicly available information. Deny it all you want. Close your ears and pretend that insiders always use the exact same information that investors have. Just know that there isn't even a trace of logic to your position.
Three insiders didn't make large purchases (including one director tripling her stake) and company officers didn't elect payment in options rather than cash because they knew a letter was coming out.
The Buy Because the Insiders Know Something thesis is still very alive.
Wow. I've never seen anyone try harder to avoid Occam's Razor in my life.
Sure, Simp. The insiders of a company that is clearly doomed (based on public info) CAN'T WAIT to lose more money in their doomed stock. They must call their lawyers every day: "Please, please, when will the window open again so that I can lose money? Is there any chance I can buy some more stock before the company gets crushed to zero next month???? Oh, when will the window open so that I can lose everything???" Yep, that would be rational behavior on their part. And a very rational argument on your part.
Good lord, month after month, they let window after window go past and buy NOTHING. Then all of a sudden, they all decide they have to buy during THIS PARTICULAR WINDOW. And buy BIG (did the lawyers tell them that they were required to buy big as well, Simp? Why wouldn't the lawyers allow them to buy small? Or sell?).
And let's not pretend that there is anything bullish about the public info. The FDA indicated in no uncertain terms that it hates SRPT's info. It doesn't matter if it looks good to message board investors. That's why the stock dropped to 12. Now the stock has risen from 12 to 17--a near 50% rise in no time at all, and you say there's no new privately available info. Oh, no. Of course not. How silly of me.
Yep, you're right Simp: 3 insiders all decided on the same day to bet enormous amounts of money based on a situation where the PUBLICLY available information has NOT CHANGED at all and in which ALL of the publicly available information suggests that a hostile FDA does not respect anything about SRPT's phase-2 data and never will. Sure. That makes perfect sense. How could I not have seen this?
No, Simp. Insiders buy all of the time in possession of knowledge the public doesn't have--especially if it's bullish information, as there are no class action suits after a company goes up. What makes a view "generally advantaged?" The opportunity to look at information other people aren't yet allowed to see.
Three insiders just bought large amounts of stock in advance of a binary event that could very easily send the stock price to zero. For those of us utilizing nothing more than publicly available information, there couldn't possibly be a riskier time to buy more SRPT. Buying before an adcom being held by a publicly hostile FDA? C'mon. Now maybe, just maybe, one insider might decide to take a tiny risk based on the same info that we have. But three separate insiders? All at the exact same time? All three making very large purchases? The only "insane" argument here is the argument that they did this based on nothing more than vague confidence and publicly available info. Rubbish. That's tantamount to saying that they all three contracted some sort of virus which causes people to want to throw their money away. Just rubbish. There is only one conclusion to be drawn from their actions: they know something. I don't know what they know, but it's clear enough that they all learned it simultaneously and all went out and immediately bought more stock--simultaneously.
Big picture: whether it's insider trading or not, something has motivated more than one director to suddenly buy large amounts of stock at a very risky moment. They could have waited another month to see if the worst case scenario was realized. They decided they couldn't wait that long. Something has to have motivated them to make these moves.
I agree that 1 and 2 could be insider trading. Now back to 3: I'm skeptical that "incremental data keeps coming in positive" (Bergycb quote) would be enough to cause two insiders to make large buys at a very risky moment just before the company could be put out of business. The FDA has formerly indicated that it is simply not impressed by positive incremental data. If this buy is data related, then it must be hugely positive--impossible for the FDA to refute--data, right? And given that the FDA seems to be immune to SRPT's phase-2 data, regardless of how good it looks, wouldn't any data breakthrough have to be showing up in Phase 3? But isn't it too soon for that? Is it possible that they're getting some early readouts that are blowing people away? And if it's manifestly too soon for blowout 6mwt data from the Phase 3, might the new data be....dare we dream it....fantastic results on the Phase 3 dystrophin measurements?
I'm still just thinking out loud, but if it isn't phase 3 data related then the only other logical possibility, it seems to me, is that they really did get the new briefing documents a month early.
Insiders are making big buys. They know something, but what? In my mind there are only three possibilities, two of which are unlikely:
1. They know something good about the FDA--unlikely. I don't think the FDA communicates bullish news to companies.
2. They know someone is interested in buying SRPT--this would be a classic reason for insider buying, but the timing would be odd. I'm rating this unlikely, though possible.
3. They know the company is in possession of very bullish data--probably the most likely.
A fourth possibility--that they have no reason whatsoever to be more bullish--seems absurd, given the magnitude of the buys.