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26/03/19
14:36
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Originally posted by Buckland:
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SC has had enthusiasm for each and every one of the products at one stage or another he may not be a sniper but i have seen some mugs missed the lot using shotguns. SO far SC has delivered very little after promising so much so really it will be a miracle if one of these products get off the ground, come on even TEVA's MAA is nearly three months behind his expected date, Artimist is nearly 12 months behind and we have heard nothing from Eddingpharm license deal done back in November 2016 - TEVA and Eddingpharm have Zolpimist which already a FDA approved product. From announcement dated 2 November 2016 "The recent in-vivo study with SUDA’s new-generation formulation of SUD-003, using the novel technology, showed a significant improvement in bioavailability (quantity of drug absorbed) compared to the Company’s original formulation. SUDA is conducting further studies with SUD-003 and anticipates meeting with the FDA to discuss the clinical strategy in CY 2017." If SUDA wanted to put out an announcement they have plenty of things they could tell us: What happened to the 2017 meeting with FDA When will the MAA for Artimist actually be determined When is the so called meeting with WHO re issues raised be held From announcement dated 7 May 2018 "The decision to meet with the WHO prior to the anticipated regulatory approval of ArTiMistby the Australian Therapeutic Goods Administration in late 2018 was stimulated by SUDA’sdiscussions with a prospective acquirer/licensee of the product. As part of the negotiation,the pharmaceutical company is seeking to know whether any further data is required bythe WHO prior to adopting ArTiMist into the Guidelines" When will the MAA in Australia for Zolpimist be submitted What has happening with SUD - 002 SUD 003 SUD 004 From announcement dated 21 June 2018 "SUDA is working with the University of Western Australia, supported by grant funding, toinvestigate the transport of *word disallowed by google across the mucosal membrane at a cellular level. Inparallel, SUDA’s formulation chemists are continuing to optimise SUD-003 utilising theCompany’s permeation-enhancing technology with the objective of enhancing thebioavailability and speed of absorption of the active drug.Several deal discussions are ongoing based on the first-generation formulation of SUD-003,covering Asia, Europe and the Middle East." "SUD-004 *word disallowed by google oral spray (pulmonary arterial hypertension)The product profile of SUDA’s first-generation oral spray formulation of *word disallowed by google, whichwas successfully evaluated in a pilot pharmacokinetic study, is well suited for the treatmentof pulmonary arterial hypertension. SUDA is discussing the development programme forthis product with a number of prospective partners." And so many more questions which they need to answer - like the so called newsletter which has just disappeared last one September 2017
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Bucky, the 003 work with hydrotropes at UWA did not work out, due to the inability of UWA to satisfactorily complete the work. SUDA was looking for another Aust Uni to carry on the work. This was mentioned at the AGM.