Yes, I understood all that. And that is what I agreed they may be doing. Their screening "halt" is either to be temporary or permanent, depending on the outcome of the submission. Sorry, I combined the two (screening halt and co-endpoint possible pursuit) it makes it confusion. I'll try to clear up what I meant:
They initiated the screening "halt". They have intentions of recruiting additional patients, and made it clear back in August that it is a screening "halt" only. I believe by their SEC enrollment statement, "bloggers turning good news into bad news" they revealed that they finished recruiting the 348-patients to the original trial design. And, the submission they referenced pertains to their regulatory pursuit of a co-primary endpoint for a regular approval pathway. If they do get regulators permission to change to the Phase III trial, they will lift the screening halt and recruit more patients to enroll an increase in "n" to which they determine is sufficient to match overall survival as a co-primary endpoint. If they do not get regulators agreement of the change, the screening halt will become permanent and they will simply announce that enrollment is complete but make no mention of changing the study accelerated approval pathway. But given the months that have gone by, and the fact that they are adding sites, I believe they are within months of getting regulators okay to proceed.
I speculate that they somehow thought that if they announced enrollment completion at 348-patients in September at the UK conference, with the celebratory drinks they had planned, and revealed at the same time they submitted something to regulators, not saying what, the market would have responded well. At that same conference, I believe their intention was to discuss HE pricing negotiations (they had Erik Ramos on the agenda at the time; his area of expertise is "pricing") along with Linda's speech. They strategically expected the news of a full enrolled study, news of an undisclosed submission, an update on Direct; and then HE negotiations update to be well received by the market. And assuming I'm correct, they had planned to do capital raises after they revealed these things, at a much higher stock and that's why they didn't raise when they had a chance over the summer. Had events occurred according to plan, no one would have realized that the submission was related to a co-endpoint change. It would be spun positive, if enrollment was at 348-patients plus. No one would have realized their intention to lift the screening halt had it been noticed a month later. But, the halt was discovered over at IV about a month and a half too soon. I believe by their screening halt comments they were initially trying to buy time to get to the September event. But their plan backfired and they needed to make an additional statement. Woodford probably is aware enrollment is complete and that's why he invested more funds. Then came the debacle over the Phase V report (talk about timing), the investigation, combined with the biotech meltdown, things went further south and well you know the rest...
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