NaughtyPines

OPENING: SRPT JAN 2017 8 LONG PUT

NASDAQ:SRPT   SAREPTA THERAPEUTICS INC
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." http://www.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: http://finance.yahoo.com/news/fda-commish-says-sareptas-dmd-142424576.html (FDA commissioner calls for correction/retraction of SRPT published study) (full memo: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary%2520review_Redacted.pdf), coupled with news of a $225 stock offering, http://www.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. http://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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