I was at the MNKD Afrezza AdCom meeting two years ago. Compare and contrast from the early pictures:
Diabetes population is 4 orders of magnitude larger than DMD. The number of of people at today's meeting is overwhelmingly disproportional.
The Etep AdCom room is twice the size of Afrezza's.
The public and political bombardment pre-meeting for ETEP is much greater than for Afrezza.
Longs should be prepared for a distressing am session. It will be scientists arguing against each other on the technical metrics of Etep. If your child does not measure up to Common Core tests, you must defend why it does not matter.
The pm is where the battle will join. The same parent with a failed Common Core son will say that her son is just as smart as any other child his age notwithstanding the bogus CC tests. She will get support from many corners.
I remember at the Afrezza meeting, the tide turned early in the pm session. I see the same atmospherics in today's meeting. If the committee goes against the public outcry, then I think their personal safety is at risk.
Hi Len: It is getting interesting at MNKD. But they need money.
SRPT is a different story. Similar to the surprise at the MNKD Adcom, I expect a surprise tomorrow.
The afternoon session at Monday's AdCom will be a passion play. Gone will be the statistical demands of the FDA. The committee will hear first person testimonies from many positively affected by Etip. There will not be a dry eye in the room.
The way I see it, if the docs think Etip is not an outright fraud, they will answer the questions positively. This gets the monkey off their backs and onto the FDA.
"I'll buy a bottle" said the shill to the medicine man. This is the type of fraud the FDA was set up to stop. For the most part, it has done a good job at a very expensive price. P3 studies typically cost tens of millions $$$.
Are the same protocols useful for the modern day? Are costly clinical trials needed to weed out the ineffective from the truly good drug? How can any DMD patient enroll in a placebo controlled study knowing he has 50% of dying early?
The FDA, being the incumbent, refuses to answer the questions directly. But they turn to the AdCom committee to find some answers. It may be that for just this case ET gets a hall pass. Or the FDA will revert to time honored protocols and call for a statistically driven (large n) study for ET.
Hopefully we will find out Monday.
I just laid off some risk by buying the weekly April 29th $5 put for $0.20.
AdCom will be a binary event. My gut instincts tells me that neither the FDA nor the committee will kill ET. The share price will percolate up to $19 where it will hold for a while.
I cannot believe my eyes. Investors who own SRPT are going crazy in the weekly put market for next week. Obviously they want to gain downside protection for their stock. But they are paying through the nose. I just sold the April 29 weekly with a strike price of $8 for a premium of $1.00 ps. That is a 12% premium for a strike price $6.40 out of the money. Incredible.
If the AdCom goes against SRPT, nobody believes the company will go away and die. ET works but not to the fussy standards of the FDA. SRPT would then reload and obtain more data.
I have never seen this in all my days trading options.
VRX's acquisition had muddled their accounting. There is concern that their non-GAAP numbers are hiding some bad truth much like an Enron. Accounting firms are keenly aware of Enron and have taken extra measures to scrutinize books before they put on their stamp of approval.
The bottom line is if VRX can spin off cash from operations to pay down debt, then there is nothing hidden in the books. This is the bottom line.
It was only a few weeks ago that WLL was less than $3.00 ps. Now it is at $9.00. Their entire 2016 plan is to hunker down for the rebound. Other frackers are doing the same.
It is time for the big boys like XOM to buy Bakken assets. WLL is a prime target. I am sure XOM tried to steal them for less than $20 ps in hopes that WLL's leverage would make them sweat. But WLL will survive and the turnaround is only months away. They and all frackers will have a mountain of DUCs to increase production so the share price will keep on rising.
How will XOM value WLL today for a buy-out? I don't think they would take less than $30 ps. I think $60 ps is more likely.
It really depends if desperate shorts got to cover. Some may want to initiate a short at this level.
I think there may be another short squeeze rally up to $9. I will get out at that time.
The recapitalization will result in dilution. Deep sea rigs will be the last CAPEX to turn around. First will be tight oil.
M&A should have happened already but didn't. I suspect the high leverage of the targets is the issue. The survivors are already been chosen. The question is will it take 6,12, or 18 months.
Oil prices will flounder around because shorts and longs take turns whacking it. A genuine $20 price is based on no storage available. That is not true yet.