Why then: 1. Did PGL delete all referene to PI88 from website? 2. Did PGL decide not to further the Melanoma trial? 3. Does their interest in PI88 resurface after being pushed aside in AVX's "expert report"? 4. Did PGL or any report attribute no value to PI88 as an asset? 5. Have no heads rolled at PGL re the PI88 trial and termination debacle?
I have taken the liberty of copying a post on Yahoot which is recommended reading for any interested PGL shareholder.
Consider the following HYPOTHETICAL scenario: None of the following actually occured. The scenario is based on purely fictitious events, dates and characters. Any reference or similartiy to an actual person, or person(s), living or dead, or actual corporation(s) is purely concidental.
Company XYZ lodges a phII clinical trial protocol with the FDA, and conducts the trial in accordance with that protocol.
The protocol indicates that patients will undergo a procedure, wait 4 - 6 weeks and then enter the 48 week trial phase - with 3 * 12 week drug cycles and 1 * 12 week follow up, (or be on the placebo arm.)
As the last patient completes the trial, XYZ releases preliminary data on the patients that it has analyzed to date.
The preliminary and final data analyses both show a similar x% increase in benefit for patients on the drug arm of the trial compared to no drug. This was calculated as follows
x% benefit = (weeks to event "on drug" - weeks to event "no drug") / (weeks to event "no drug") e.g (30-17)/17. = 76%
Money is raised specifically for a PhIII program.
Subsequently XYZ has trouble convincing the FDA about the merits of its putative phIII trial design and there are long delays.
Approximately 12 months after the release of the first data, a series of announcements appear, with a new cut of the data, and a statement that the previous data reported included results on the 48 weeks "from the procedure".
Now consider the following questions.
(i) did XYZ's first reports (interim and final) include patients in the 4-6 week latency period as part of the 48 week "on drug" number?
(ii) if XYZ did do (i) above, would the FDA have spotted this in the SPA process? What would the consequences of this be?
(iii) if XYZ did do (i) above, would potential partners have spotted this in the clinical data pack? What would the consequence of this be?
(iv) if XYZ did to (i) above, would any other regulatory authority have spotted this ? What would the consequences of this be?
Now consider this additional HYPOTHETICAL situation:
If the slopes of the trial data curves ("drug" and "no drug") were near linear, and/or highly correlated, would the absolute value of "x", as calculated above, be any different if XYZ had correctly analysed and reported from the time the patients actually started taking drug, that is week zero, as per the phII design lodged with the FDA, vs. week "T-6" (i.e. immediately after surgery).
(v) if XYZ did do (i) above, would they be obliged to tell investors about it, given that the correct analysis, over the correct time frame, possibly produces a similar "x" that they originally reported, possibly based on an incorrect calculation?
Further questions.
Who do the existing directors of XYZ owe a duty of care to?
Who would potential new directors of XYZ owe a duty of care to, assuming that they knew nothing about this prior to being appointed to XYZ?
If the directors of XYZ were found to have acted contrary to their responsibilities - what are the potential liabilities of XYZ or its directors?
Who could potentially have a claim against XYZ, its directors or its former directors?
What could be the potential magnitude of that claim?
Does XYZ carry enough insurance to cover a damages claim that is potentially in excess if its available liquid assets?
PGL Price at posting:
84.0¢ Sentiment: None Disclosure: Held
