Reading the article on the approval for FSD, it shows the FDA is providing good flexibility for first in class therapies including Eteplirsen. Below is a paste-in:
In a report issued Wednesday, Roth Capital Partners analyst Debjit Chattopadhyay, Ph.D., looked into the event and the consequences it has for Sarepta Therapeutics Inc (NASDAQ: SRPT). The expert concludes that this move by the agency can be seen “as another sign of flexibility especially for first-in-class therapies,” which bodes well for eteplirsen (from Sarepta), drisapersen (from BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)) and Translarna (from PTC Therapeutics, Inc. (NASDAQ: PTCT)).
The note highlights a few key points to take into account:
o While FSD is a clinical problem, eteplirsen is designed to save the lives of many people succumbing to DMD in their mid-20s.
o Several “ongoing studies clear an important bottleneck.”
o The re-scoring of Dystrophin eliminated “the second key bottle neck allowing NDA submission to proceed (...) Positive findings support the mechanism of action of eteplirsen.”
o The fourth biopsy analysis is being completed in the most robust way possible.
o Roth Capital expects NDA acceptance within the next few weeks, with no RTF given the interactions Sarepta has had with the FDA over the past three years.
So I've heard rumors (twitter) that the Beta is really good. I haven't got my Beta product yet - and I want it.
Google glass was such a disappointment. I hear this is a much better engineered product (though very different to be sure).
Feb 2005 I see BMRN at $5.37/share. That is the lowest I've found in the 10-year chart. Great returns but hard.y "a few years ago"
What a great testimony to the efficacy of Eteplirsen and a great hope to all those afflicted with DMD.
Finally they are launching the beta. Will receive mine in the next 2 weeks. Others will get their notices in the coming weeks after (FIFO queue). This is progress finally and we should see a commensurate uptick in the share price to match. Especially if the Beta is a good product.
I hope, because I have a *LOT* of customers with applications they can use this for.
Amazing returns can be made in the Pharma space. I missed that one, but I'm going to get all of SRPT.
As much as I *HATE* dilutive secondary offerings, I believe RDUS will bounce right back. I'm so confident, I'll buy more at anything under $75 tomorrow.
If the FDA did not accept the application then yes, most likely back to $15. However, that is extremely unlikely given the level of cooperation recently between the new CEO & the FDA. Previously when there were issues, the FDA was quite blunt, telling SRPT not to file. That has changed now, leading us to believe things are OK now.
I would assign a probability of less than 5% of that the FDA would not accept the NDA.
True the 1-year chart is the other way around, but that was because SRPT was making stupid moves at the CxO level, which has hopefully changed now.
Pull up the Yanoo chart then add the other stock symbol under comparison. Very interesting.
So now the guys in my investment club are telling me to take the 15% quick gain and run (sell). My gut tells me this is going significantly higher. No rational basis, just instinct tells me to hold on for more.
The price move yesterday combined with the strong volume could indicate a buyout is in the works. It would not be unreasonable for a competitor or someone looking to get into the product space to snag a company with good technology cheaply to rapidly advance the race.
No real driving reason for them (FDA) to get it done early. 60-days is the norm.
I've been admiring RDUS for a while now and every time I go to buy it, it spikes upward. So I kept waiting for the inevitable pullback. I regretted waiting and today I got my chance to start buying RDUS. Only 1/4 of what I want so far, in case it falls further, but my gut instinct tells me I'll be buying at higher and higher prices.
While some salad junkies don't get it, ISIS doubled since a year ago. Yes, that will give room for some pullbacks but in the long term it will double AGAIN from here (long term meaning a year from now).
Are you really that stupid? The value of the stock is the shareholder value, has very little impact on the company itself. Sure if they were going to do a secondary offering it would have an impact, but that is about it. It has no impact whatsoever on the company.
The pipeline ISIS has is the richest in the industry and is irrelevant to the stock price, movement, etc.
Do you really not understand 1st grade level market mechanics?
I've been too busy lately & need to catch up please. How do you know Henri Termeer is considering coming on to Sarepta - that he is interested in them, and them in him? Don't get yourself in any trouble or reveal more than you wish, I just didn't know about it until I read it on this board.
Thanks in advance.