I agree Southoz - no point speculating on the outcome of the AdCom, we are all locked in now.
At this point in time, however, I thought it might be nice to reflect on the history of QRxPharma. So here is a little timeline of key events that I compiled for myself some time ago.
Enjoy, and good luck to all holders and QRxPharma!
2002 - QRx established by UniQuest to commercialize technologies developed by UniQLD academics. Had two components which later separated: (1) Pain management, which continued as QRx; (2) Anti-bleeding agents derived from snake venom, which split to form Venomics in 2009. On the pain medicine front, the two UniQLD academics behind the research were: (1) Professor Maree Smith (http://www.uq.edu.au/pharmacy/maree-smith); (2) Associate Professor Fraser Ross (http://staff.qut.edu.au/staff/rossfb). Australian and international venture capital of A$10M was secured - possibly the largest first round investment for any Australian start-up at the time. This capital funded the development of the company & its most advanced drug candidate, MoxDuo.
26 May 2007 - ASX listing and IPO. QRx floated following the completion of Phase II trials and FDA approval to start Phase III trials for MoxDuo IR. Successfully raised $50M through issue of 25M shares at $2.00 per share. At the time, it was the largest Aus biotech capital raising at an IPO. Initial market capitalization was A$150M making QRx the largest Aus biotech at the time.
Nov 2009 - Further capital raising of $21.6M. Price dropped from $1.27 down to $0.80
Sep-Oct 2010 - Further capital raising of $19.8M. Price steady at $0.90.
Nov 2010 - Awarded US Gov drug development grants of $0.5M Price up from $0.90 up to $1.15.
June 2011 - Phase III MoxDuo trials completed. Price ranged $1.60-$1.75.
18 July 2011 - Preliminary New Drug Application (NDA) filed. Price = $1.50.
20 July 2011 - Further capital raising of $35M. Price from $1.50 down to $1.10
25 Aug 2011 - NDA filing completed. Price up from $1.35 to $1.70.
8 Nov 2011 - FDA sets PDUFA for 25 June 2012. Price = $1.60.
21 Dec 2011 - QRx announces partnership with Actavis for US market. Price up from $1.20 to $1.50
11 Apr 2012 - Phase 1 Trial for MoxDuo CR completed. Price = $1.70.
27 June 2012 - PDUFA results in Complete Response Letter. Price drops sharply from $1.70 down to $0.60.
FDA confirmed Combination Rule Study (Study 008) satisfied efficacy requirements and there were no unexpected or problematic safety issues in any of the studies submitted. However, FDA requested: (1) further information on data filed as part of the NDA; (2) additional analysis of clinical trials, particularly Study 022, as the analysis of Study 022 was completed after the NDA filing (although early safety data were included in the 120-day update).
10 Oct 2012 - Announces partnership with Paladin for Canadian market. Price up from $0.68 to $0.75.
16 Jan 2013 - FDA clarifies pathway for resubmission and approval. Price = $1.25.
Informed QRx that the resubmitted application will undergo review by an Advisory Committee to evaluate the approvability of MoxDuo. The reason, it said, was because no precedent exists for their review of combination products in which two drugs from the same category are combined (e.g. morphine and oxycodone are both “opioids”). The FDA also recommended the Company provide more extensive analysis of Study 022.
28 Feb 2013 - QRx resubmits NDA. Price = $1.10-1.30
Updated NDA includes: (1) comprehensive analysis of Study 022; (2) results of five other Phase 2 and 3 clinical trials which show MoxDuo is accompanied by less nausea, vomiting, itching and headache; (3) MoxDuo provides a safer starting dose and finer dose titration steps.
14 Mar 2013 - FDA sets PDUFA for 26 August 2013. Price = $1.15.
17 May 2013 - FDA sets AdCom for 17 July. Price = $1.20.
26 June 2013 - AdCom & PDUFA postponed (3 month delay anticipated). Price drops from $1.15 to $1.00
22 July 2013 - Collaboration with Aesica to commercialize Stealth Beadlets. Price = $1.00-$1.05.
28 Aug 2013 - FDA issues CRL to allow refilling of NDA (6+ month delay). Price drops sharply from $1.10 to $0.75.
11 Sep 2013 - Announces license deal with Aspen for commercialisation in Australia, NZ, and Oceania, and an option for license to commercialise in South Africa. Price = $0.75.
15 Oct 2013 - Announces confirmation of license deal with Aspen for commercialisation in South Africa. Price = $0.66.
11 Nov 2013 - Announces Capital Raising (subsequently successful raising of $11.6M = $7.5M institutional and $4.1M SPP). Price drops sharply from $0.71 to $0.63.
26 Nov 2013 - NDA refiled with US FDA. Price = $0.60.
27 Nov 2011 - Announces license deal with TEVA for commercialisation in Israel. Price = $0.62.
22 Apr 2014 - FDA Advisory Committee. Price going into AdCom = $0.70.
25 May 2014 - PDUFA date – FDA will say yes or no to Moxduo sales in the US.
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