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Msg  2668 of 2804  at  6/13/2019 12:23:18 PM  by


The following message was updated on 6/13/2019 12:48:39 PM.

Odds & ends

(1) IMHO Sun generic filing is a non-event.  If anything it increases the incentive for Teva to settle as opposed to try via IPR to attack the patents.  This being so because if the patents are invalidated (at end of IPR process after appeals in say 2021) then that clears the path for Sun to launch right after the 180 day exclusive period that Teva enjoys.  If on other hand Teva settles with CORT, then Sun has to get around the patents (and the 30 mo stay, etc.), which delays Sun till 2022.  BTW the cost to CORT from filing another lawsuit and starting the 30 mo stay is trivial
(2) Speaking of Teva the usual back and forth in the NJ case, which is about a small (trival) matter of who gets to see Teva confidential discovery material and how the person who sees it is barred from using it for other purposes.  IMHO all this further delays the process....without any purpose other than to increase legal bills.
(3) IMHO that we may hear a bit more on Pancreatic on the next qtly call in Aug.  Keep in mind that CORT is getting lot more data.  For example the ASCO abstract showed data on 27 pts, then the poster showed that 33 pts had been enrolled.  And with trial overall (for all tumor types) being about 50% enrolled, I think we get data on those (33 pts) plus others that are being enrolled for a total data set of 50 subjects before the next trial design / endpoints / FDA agreement all falls into place.  All this could happen in Q3 / Q4 but being Corcept it may be early 2020 before the trial gets launched.
(4) Focus on Cushing's Relacorliant trial seems to be paying off.  Clinical trials was updated yesterday to show that 18 sites are recruiting.  Joe had mentioned total of about 50 sites by year end, so they seem to be on target to get that trial enrolled by Q1 2020, with a readout in early 2021 (thus before the timeline of earliest Teva launch). 
(5) Last, but maybe most importantly, the '335 anti-psychotic wt gain trial (in healthy subjects) is underway.  Listed with completion in Sept, so maybe on Q3 call we hear about the results.  If positive this greatly de-risks the metabolic opportunity in using '335 to mitigate weight gain (remember that Mife has shown to work, so now if '335 shows promise, chances of success IMHO become about 80%).  This could be larger than a Cushing's sized opportunity.

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