There was a Press Release on HPPI's website from two days ago...

There was a Press Release on HPPI's website from two days ago (quotes below), basically approval seems to be happing relatively fast (not that i have any experience in such things), and it appears the announcement was well received judging by HPPI's share price which is up 15% in two days, very high volume on the day of the announcement.
Mayne owns 197m shares in HPPI (53%).


PR from HPPI website below
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“We are pleased with the FDA’s guidance, since we believe it adds clarity to our regulatory and clinical road going forward for the BCCNS indication of SUBA-Cap. FDA confirmed that we may follow the more streamlined 505(b)(2) regulatory pathway, which will allow us to reference safety data from previous third-party itraconazole trials, to be supplemented by our own safety database. The acceptability of this combined safety database will then be determined by the FDA during the course of its review of the future NDA. FDA also agreed that no additional nonclinical toxicology studies appear necessary to support filing an NDA for SUBA-Itraconazole under the 505(b)(2) pathway.”

Importantly, FDA also indicated that it “[w]ould accept a single study to support an NDA if results show a significant effect on a clinically meaningful endpoint. The results of the single trial must be sufficiently robust and so compelling that it would be unethical to repeat the study . . . [e]vidence of an objective reduction in tumor burden that is durable is important in order to demonstrate antitumor effects of SUBA-Itraconazole in patients with BCCNS and these data should be collected and independently reviewed.”

Mr Virca further stated that, “In light of FDA’s additional guidance on what might constitute a clinically significant response, we are now undertaking further detailed analyses of individual tumor responses from our ongoing trial seeking to verify the robustness of our therapy in reducing the tumour burden in BCCNS patients. We intend to present the results of this additional analysis to FDA and continue discussions with them about the utility of such results in a potential NDA submission."

http://docs.wixstatic.com/ugd/041d82_97747b7490544f99aa3f758dac510240.pdf