Great post! I see all of FDA's whining post-approval to be consistent with their pre-approval objectives and with an inability to deal with the fact that mamma Woodcock spanked their backsides.
Has it ever been prescribed for non-ambulatory patients? The purpose of the drug is to sustain or increase mobility. Consequently, their tough talking policy would exclude no prospective patients.
My reservations about world markets, D Banks $70tn in derivatives wobbling worldwide and saber rattling between the U.S. and Russia aside, I still believe Sarepta is the best investment available in the depressed biotech sector. Additionally, I remain hopeful that a buyer will appear. As previously stated, finding Kaye $10m in parting gifts is the essential obstacle to overcome.
Also of note, when an offering is executed at such a high price, it's normative for purchasers to protect their holdings by shorting their shares. While I can't tell for sure, I don't believe this has happened. Therefore, I remained convinced that buyout negotiations are taking place. Nick Domenico's post on October 14th was right on target.
Biotech is like a Rollercoaster. If you can't enjoy screaming on the downward plunge then don't get on in the first place.
Sentiment: Strong Buy
That's about right. Publicly work with the skumbag shorts to drive the stock price down while privately doing the right thing. Reversal on policy announcement coming soon. Qareful Qwashed.
Look for an Anthem reversal within the next few weeks.
The same can be said for many approved therapeutics including the ubiquitous Tylenol (acetaminophen). There are several theories but none are backed by conclusive scientific evidence. That, however, hasn't stopped numerous medical professionals from prescribing it, millions from taking it and hundreds from dying each year because of it. Perhaps Jenkins can tell us why Tylenol got approved in the first place.
Impressive response. The amount received will also determine how much of an impression the sale makes but I agree with this post.
Hmmm, it's not uncommon really. Trevena made the same transition. Plus, they're making DMD a focal space which makes sense. Thanks for the update.
One last thing thig, what's up with the flu data? Are we going to get a read on that trial soon?
I'm glad you added this color to the conversation. I would go a step further, having watched Jenkins in action, and state that he's a hatchet man for big pharma. He had (Jenkins) an introductory video on YouTube in which he stressed the need for flexibility in new drug applications, amongst other things, and then this. So typical. Too typical. It's a club man. And notice how it's been Cahill and Jenkins on the record. Farkas was shipped out to keep him quiet. Wise choice me thinks.
If you're right, and you very well could be, I'll be the happiest guy here. Your 2nd thumbs up is from me.
The FDA continues to express their unrelenting animosity toward Sarepta management by publicly humiliating the company in the wording of approval (now known as the 126 pages) and by publishing clarification of policy as it relates to Accelerated Approval (see John Jenkins letter today) but I didn't anticipate it being this bad. It could, of course, get worse. There might be an official policy revision in the works and EMA authorization jeopardized by Jenkins' harsh assessments. It's never easy being in the wake of FDA's wrath (see AMRN and MNKD). Those who thought it would be have now been fully disabused of their denial.
I invested my profits in a new position in SRPT now 20% underwater because I thought Kaye would have had the wisdom to partner with big pharma in order to gain a trusted voice within the agency to smooth over the vitriol that remains. Unfortunately, I now simultaneously believe that Kaye is as naive as many of the longs here, and that FDA wants nothing to do with Sarepta or anyone associated with the company. Consequently, a sale is now mandatory if eteplirsen is to have a commercial future. Even more unfortunate is that the possibility has become more remote.
Kaye simply doesn't have enough shares of SRPT to make a buyout worthwhile from his perspective. The Summit partnership brought with it a likely extension of his now unappended title of CEO. This is worth $20m to him over the course of 10 years assuming $2m in annual compensation. The most likely suitor is Biomarin as they would save on litigation expenses and recover their lost footing in DMD. The problem would be finding half of that $10m as a means of motivating Kaye. And because Sarepta largely remains a developmental venture as commercialization is tentative, the price paid would be no more than say $5.5bn. That would make me happy but the rest of you would likely sqwauk about being sold out.
Sans a buyout, share price ascent remains a fettered proposition. Long SRPT!