30 day FDA clock countdown is on!, page-66

Give them a break SG, an informed investor who reads this site already knew the PCH update was coming in the annual report, and why would an announcement of the results of a HSG reanalysis of Reach2HD results need to include anything about the PCH.

"Using NLP methods to extract relationships and meaning from large text-based resources, such as the HD-PROP verbatim data, word clouds (images composed of words from a text where the size of the word indicates frequency or importance) were derived from the HD-PROP data in the Reach2HD trial at baseline and week 26. The Reach2HD NLP data showed a decrease in “memory” complaints at week 26 in the PBT2 250mg treatment compared with placebo. This improvement in cognitive function using the NLP computer based examination of the patient reported data, supports the positive cognition findings with PBT2 to date from both the HD-PROP assessment and the TMTB rating scale."
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I take your point on the non price sensitive nature of the PCH submission. The last run up to trial results happened over a 2 year period from 2012 to 2014. That is hardly a spike, and it is a trial start which could follow the data package FDA response.

In the December half yearly Prana stated "It is essential that this submission presents sufficient data to enable the FDA to give guidance on the next steps required to lift the PCH and it remains a priority for the Group. "
The language in this Annual report is a little more positive. "The US Food and Drug Administration (FDA) currently has a partial clinical hold on PBT2 that limits the dose that can be administered in trials in the US. In response, we have submitted a strong technical and safety data package, incorporating our Phase 3 HD trial design in support of lifting the hold."