explanation, page-68

Aaah the rum will do that to ya, but it tastes so good:)

Do look at intraday lows as anything significant or does the closing have more of an effect? I see as toe dipping and rejection, that's my technical term, lol.

As far as the FDA is concerned nobody really has any idea and there is a big backlog with them. The only thing we can say as holders is that it was meant to be a 6 month process and that has passed, though to me this means that we could find out at any time - days/weeks/months as to what the outcome is.

From the Half Yearly the other day (read into it what you will):

?At the time of the filing of the fondaparinux ANDA by our US marketing partner Dr. Reddy?s Inc. in March 2009, we hoped that approval could have been granted by the end of 2009. Whilst this milestone was not achieved, we are not aware of any unordinary issues specific to our ANDA that
has impeded its progress. Recent communication from the FDA has confirmed that the ANDA for fondaparinux continues to be under active review and that the file is continuing to make progress.?

As for the phase 3 clinical trial (of HA-irintecan I gather you mean) I think this (below) explains it best from the Half Yearly. Getting to phase 3 is hard enough for any company so this will add weight to the shareprice in my view once FDA for the generic is given:

"One of the primary objectives of Alchemia?s clinical team over the last year has been to continue to develop and confirm the global regulatory strategy for HA-Irinotecan, ensuring that one final pivotal trial, if successful, will provide a rapid route to market. In June 2009, Alchemia met with the FDA and presented a modified Phase III study where it was agreed that the trial design was acceptable and if successful, only one trial would be required before it was possible to obtain market approval for HA-Irinotecan.

The modified Phase III trial is expected to be as follows:

randomised and double-blinded: neither the patient and clinician will know which
treatment is being administered;

330 second-line metastatic colorectal cancer patients;

half of the patients will receive Alchemia?s HA-Irinotecan in combination 5-fluorouracil and
leucovorin (test arm) and half will receive unmodified irinotecan with 5-fluorouracil and
leucovorin (control arm);

to be conducted over several sites and regions, including the US, Europe and Australia; and

the primary endpoint will be progression-free survival (PFS).

In addition to gaining further support of Alchemia?s clinical and regulatory route to market, the extensive planning and implementation of the pivotal clinical trial is in the final stages of preparation. The Company has completed the bid defence process for the selection of a global Clinical Research organisation (CRO) to conduct and administer the trial. It is anticipated that recruitment of patients to this trial will commence around mid-year (contingent on FDA approval of fondaparinux).