Galectin Therapeutics Inc. (GALT)

[sunspotter]

Looks like the Prospect law suit is going badly, to say the least. Pro-Pharmaceuticals nearly lost by simply failing to show up:

"On December 12, 2008, in response to a motion for withdrawal by counsel in this case, the court amended its order dated October 6, 2008 to state that by January 9, 2009, a default judgment will be entered against us if new defense counsel has not entered an appearance on our behalf or we have not restored our relationship with our current counsel. On January 7, 2009, our successor counsel entered a notice of appearance to represent us at trial which commenced on March 10, 2009."

They have to admit in the filing that the results obtained with Davanat are equivocal to say the least:

"We have one drug candidate in clinical trials and results are uncertain......[This trial] may not start or be completed as we forecast, or may not achieve desired results."

Unbelievably, even though FDA have explicitly told them they need a Phase III study and a proper pharmacokinetic characterization of Davanat in order to gain an NDA for the product, they persist with the 505 (b) (2) fiction:

"Our 505(b)(2) NDA for DAVANAT® will seek FDA approval for co-administration of DAVANAT® with 5-FU for intravenous injection for the treatment of colorectal cancer. These 505(b)(2) NDAs are often used for drugs involving previously-approved products and, as a result, are less costly to prepare and file with the FDA."


This is deliberately misleading and actionable.

Obviously, "the Company’s recurring losses from operations and stockholders’ deficit raise substantial doubt about its ability to continue as a going concern."

It's not clear from the accounts how much cash they were able to siphon off to Platt under cover of compensation for loss of office etc. The 2009 Proxy statement may reveal this when it's issued, although I suspect we'll have to wait for the 2009 10K, which I believe will never be issued.