Decided to start a thread name I liked better.... but thanks for...

Decided to start a thread name I liked better.... but thanks for the sobering post Thwack and thanks HoundZ11 for some great additional information on recent market developments that I hadn't seen.

Thwack - Your post was particularly good for me in that it made me immediately go back through the reasons that made you "suspicious of any firm that delays reporting to market ", and their use of "adjectives" in updates etc which concerned you... I guess to counter your argument from their own updates - Observations re: HA-I Phase III that make me more comfortable:
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3/1/2012 - Trial starts - first patient receives treatment
25/9/2012 - over 215 patients enrolled, and Alchemia noted that and trial may be delayed despite enrolments on time/budget... also they note 82 patients had received 10 or more treatments. My observation - in phase 2, patients were on average receiving 6 treatments of HA-I compared to 2 so 82 patients receiving 10 seems significant.
4/2/2013 - Update - 390 patients recruited by 31/1/2013 and patients were receiving more treatments than expected "Company’s initial expectations, based on historic data, anticipated 350 patients would have experienced disease progression in the second half of 2013. However, statistical review and modelling on the available blinded data suggests that on average, patients on this trial are continuing treatment for longer than anticipated, before their disease progresses. While the Company is encouraged by this observation, this means that the primary the endpoint is now likely to be met early in 2014". (italics mine)
28/11/2013 "The DSMB's fourth recommendation to continue our Phase III clinical trial of HA-Irinotecan represents the achievement of another important milestone in the progress of this pivotal trial" said Dr Tracey Brown, Chief Scientific Officer of Alchemia. "The independent DSMB reviewed data generated from the administration of over 4,500 chemotherapy treatments (italics mine) and it is reassuring to know that we can continue treating patients safely. The trial appears to be on track to reach the primary end-point in the first half of 2014.”
My observation: I don't think that I had ever noticed that the 4th DSMB review had worked with that much data, seems a lot of treatments - is that also a further clue to the ongoing performance?
5/6/2013 Peter Gibbs: “HA-Irinotecan has the potential to become the standard-of-care in metastatic colorectal cancer. I look forward to the opportunity to work with Alchemia on educating the oncology community about the value of HA-Irinotecan and CD44-targeted drug delivery.”
12/9/2013 - "Potential for HA-Irinotecan.... to be a new addition for treatment options for patients with colorectal cancer and also as a major milestone in the history of Alchemia".
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So, in summary, firstly, I'm not sure how much more they can do to update us on a blinded trial because from fairly early on, every update basically, they started flagging possible delays in achieving the endpoint on original timeline and the reasons for delays have gone from being "encouraging" at the beginning and lately have become "exciting" with some big "potential" statements to accompany their updates. So to me, they're doing all they can with the data to reach an endpoint that they've had to extend on multiple occasions... but the extensions may, at least in my rose-coloured glasses biased reading of their updates, be pointing to increased performance of HA-I in the trial. I believe they've been open, and transparent (as possible) with the progress of the trials and I don't think they would spend time "meticulously handling data for FDA submissions" to paraphrase Tracy Brown, if they could instead choose to lock, unblind and announce sooner.

Secondly, while commercially Alchemia has left a lot to be desired IMO with the misunderstanding/mishandling of the first "black swan" being generic fondaparinux, the financial troubles of profit-sharing with Dr reddy partnership, and the failed Audeo listing - I think historically the Alchemia science has stood up. They successfully developed fondaparinux and got it through FDA and to me, based on Phase 2 and current guidance - everything points to HA-I following the same path -albeit on a greatly extended timeline to what we, and they, may have initially hoped. Additionally, the quality of the new executives/management that have been keen to sign on in the last 18-24 months, post all those "black swans" would also suggest some level of excitement around the progress of this trial, and hopefully the firepower to better guide Alchemia commercially if this does prove to be a major milestone in Alchemia history.

Finally, I'd like to acknowledge that by taking a 50% profit off the table, Thwack, from purely an investing point of view you've done much better than me at this point in time, and like you say - your risk is now gone. However, I'd like to think despite those obvious risks, there's a reasonable chance of success from here, and with current guidance ranging from "encouraging" to "exciting" I'm comfortable (enough) holding and even buying at this level for the reasons outlined above...

All that being said - I am REALLY looking forward to knowing once and for all whether HA-I works and whether my faith in this endeavour has been well placed or not... and come sometime in October, if the statistical improvement isn't there to prove this as a viable future cancer treatment.... I can finally forget Alchemia (as I'm not holding this for Fonda value!), and find another place to invest my time, money (what little is left of it) and emotion.