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NaughtyPines
Sep 20, 2016 1:01 PM

OPENING: SRPT JAN 2017 8 LONG PUT 

Sarepta Therapeutics, Inc.NASDAQ

Description

Shooting for an .08 ($8) debit fill here. It's a lotto trade (which I hardly ever do), but I think that the drug will ultimately not be approved.

The potential profit is 795/contract, but that's if the stock goes to "0." Additionally, it will only "play out" if there is news prior to expiry. Otherwise, it'll stay way up here.

Comment

Filled for an .08 ($8) debit per contract.

Comment

Here's the basis for this trade that was buried in the accelerated approval announcement : "A clinical benefit for EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials." marketwatch.com/story/advancing-preclinical-autoimmune-studies-accelerated-fda-approvals-producing-rewards-in-biotech-sector-2016-09-20 These confirmatory trials are likely to take more than a year (possibly two) ... .

Comment

I'm getting a lot of StockTwit flack on my assessment of this therapy ... . Lol. Here's my basic point: the fact that "no clinical benefit" has been established for this drug up until this point means that all Sarepta's being allowed to do with this "expedited approval" is continue to administer the therapy and collect data in an attempt to prove an efficacy case that they have not been able to do up until this point (granted, the last clinical they did was a total procedural train wreck -- no control, too small a study group, etc.). They won't be able to run the confirmatories indefinitely without either admitting that the therapy is not efficacious (a la NVAX) or eventually presenting an efficacy case to the FDA. Given the fact that (1) a similar therapy failed to receive FDA approval on efficacy grounds; and (2) SRPT has done nothing so far to present scientifically valid efficacy data, I'm betting they won't be able to pull a "rabbit of a hat", regardless of the amount of time they're given.

Comment

This stock appears somewhat bullet-proof. There's this: finance.yahoo.com/news/fda-commish-says-sareptas-dmd-142424576.html (FDA commissioner calls for correction/retraction of SRPT published study) (full memo: accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary review_Redacted.pdf), coupled with news of a $225 stock offering, marketwatch.com/story/sarepta-sales-slump-after-company-announces-225-million-stock-offering-2016-09-21 Nevertheless, up ... . A head scratcher.

Comment

SRPT now in horse race with SMMT. seekingalpha.com/news/3210719-summits-ezutromid-fast-trackd-duchenne-muscular-dystrophy The "bad" thing for SRPT is that SMMT therapy would treat all DMD, not just the ~13% of all DMD cases that SRPT's drug targets (amenable to skipping exon 51). SRPT looking less and less attractive, imo ... .
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