Not an ominous claim and I have no "motives"... the observation is that IF Tak Mak is acting on material fact not available to the general public, then this would be considered "insider information" ...ie., IF he was in possession of non-disclosed information coming from the P2 (or any other trial) as a consequence of his relationship with Enmd as an investor (5.1M SVT), plus other shares transferred in the purchase of Miikana, plus the shares earned from the bench mark payment at the P2 start up, plus his relationship with PM Hospital where the first P2 trial began, is on-going and nearing completion...

I don't understand the "attitude"... what's your problem?

...well then, my friend, maybe you shouldn't post when you are tired...

There are not many people who would appear to have a greater insider attachment to Entremed than Dr. Mak. Did I mention, besides all of the other things menitoned, he is the one who brought E2076 to Entremed as one of the principles of Miikana???

If you expect this board to be one of agreement with your views only... you are mistaken.

...totally agree... and importantly, insider trading does not just apply to "widely traded companies" with "idiot CEOs" and "ditzy celebrity investors..."

This isn't going anywhere... I respectfully decline further comment... good luck...

Miikana Inc. a wholly owned subsidiary of Entremed
TWMak a principle of Miikana
TWMak major stock holder in Enmd
TWMak affiliated with Princess Margaret Hospital in Canada where P2 trials are underway.
TWMak principle of SVT ventures which acquired $5.1M worth of Enmd Stock and rights to develop and market E2076 in Canada

you are joking!

...you are joking, aren't you...

...if ever there would be a text book case for insider trading...

I agree with you. I can see where the technicals may apply to a heavily traded stock...but I have difficulty seeing the validity of using this type of analysis for a volatile and speculative stock and especially those that have no marketable product, income stream, or profit and threfor, no measurable value of the pps...

the pps is currently dependent upon speculation and what people are willing to pay for it... there is no stability and will be none until there is a marketable product...

OT...so all day yesterday "...it was dejavu all over again..."... the name Celgene kept popping into my head, along with "licensing rights..." and "...milestone payments and royalties..." and a right to "...have a seat at the board..." ...I looked up SVL to see what their stock was worth... privately held...

Thalomid... revlemid...

...and VK... my dog Murphy, an Irish Setter... ran off to see Prince Poppycock...

What does all this mean?

...don't have a handle on the strategy behind the deal... other than cash infusion...

The option for SVL has a relatively short exercise date... December 2011...

Where's the other shoe?

...well... China???... was this a last resort? What effect will it have on future partnerships... from an international perspective... they have split off half the world...

Doc Rubber Chicken has a nice ring to it..."Calling Dr. Rubber Chicken... Dr. Chicken, please proceed to the ER... Dr. Fox is requesting your assistance..."

It's possible... but if they were experiencing success why would they jeopardize that by lowering the dosage... and if not... why go to a lower dosage?

If the reasons were to do with adverse effects... this is usually a reason to stop the trial...

Not much makes sense at this point...

If the higher dose produced adverse indications, it does not seem at all logical, or within the FDA purview, that the dosage would be simply lowered and the trial continued.

The MTD of 325 mgs. was arrived at in the P1 trials. So it does not seem likely that toxicity was a reason for lowering the dosage. It does seem likely, that the dosage was reduced downward to 275 mgs. based upon the gender difference in body mass, and, in fact, it may not have been a change at all, but rather an acknowledgement... a restatement of the actual dosage being used..

Short of some sort of clarification by ENMD/FDA... there is no way to know for sure...

I think George's comment (on the dysfunctional board) regarding the dosage in the P1 trial and the difference in gender body mass may be the explanation...when adjusted for females, the adjusted dosage closely parallels the dosage for males...

This may not have been appropriately defined at the trial onset (application) and the recent news may not have been a correction in dosage, but merely a restatement of dosage.

lol...i resemble that...

sup, Compost?

Did you just come across the clinical trial data at the gov site or was there some sort of news item on the change in dosage...

The silence is killing me...

thanks...

Actually, that sounds quite reasonable...

Is anyone aware of any historical precendent??? Other clinical trials where this type of action occurred and the reasons why???

My argument is that it is unlikely, based upon the P1 trials, that they could make this judgement unless there was some linear variable that was causing most to experience the same "problem"...

If toxicity were an issue at a higher dosage, how do they know the problem will go away at a lower dosage... I could see stopping or suspending the trial for reevaluation... but to simply lower the dosage and continue does not make sense...

Again I think it was a linear problem experienced by many...i.e., increasing BP, or some other predictive indicator.
And I think we need to be prepared for the fact, that if the corrections made are not effective, then it is likely that the trial would be cancelled... this of course is supposition that there was adverse circumstances causing the change...

I share your concern... but mostly because there seems to be quite a few parts missing... It doesn't seem logical that the dosage would be reduced based upon toxicity... and it doesn't seem likely that the entire patient population would respond uniformly... and those who did experience adverse reaction would most likely be dropped... isn't that generally written into the trial design?

And, if it is a gender issue... wouldn't this have been demonstrated in the p1 trial???

However, if there is a linear trend of a metric...e.g. increasing BP or similar metric... it would make sense that the dosage would be reduced because of predictive concerns for acute life threatening reactions.

I agree that it is unlikely that the dosage is being cut back because it has been determined that a lower dosage would be equally effective. That would be great news... but it doesn't compute. This would be experimentation with the patient, not treatment of the patient.

Finally, if toxicity was acute, it would make equal sense that the trial would be discontinued...

There is much more to come... I've got to believe it was a predictive concern.

I had the privilege of speaking with Jo Ellen Thornton in a phone conversation a few months ago...At the time she was very upbeat, and engaging. She was very positive about her participation in the 2076 trials and actually became an investor in ENMD.

At the time we spoke, she had been taking 2076 for about 18 months and felt strongly that she had not only been given the gift of time... but the gift of quality time... she was able to travel and do the things she loved in life not having to experience the debilitating side effects of some of the other chemo choices available to her.

She was an advocate for 2076 and for those afflicted with the disease and much of her travel involved speaking to support groups and individuals.... offering encouragement and hope... never complaining and always positive about her future and of those she engaged.

After many months of PFS her CA125 numbers began to rise and she left the trials and began taking carboplatin again... she had hoped to enter the P2 trials, but was not eligible.

Enmd 2076 provided an 18 month reprieve. A period of quality time, perhaps not otherwise available, in which she was able to go diving in Mexico, spend time with her children and grandchildren, and to provide comfort and hope to all those with whom she came in contact.

And importantly, this is a reminder that there is no magical "cure" for cancer, but there is hope, as we increase the time of progression free survival, that it will one day become a manageable disease in which a person may die with it, but not from it.

Jo Ellen Thornton is a hero.

You are a hero, Norman... this comes under the heading of... "...you can't keep a good man down!..."

Hang in there, Norman!

I sure hope it wasn't a problem in the Enmd lab...

:)

Hey George

I just bid farewell to the Yahoo Board... suggest you do the same... let them self destruct...

Thanks, George...

A few weeks ago someone started a dialogue with a newly enrolled Ovarian Cancer patient in the P2 trials... there were a couple of posts by the patient... at the time I had mixed feelings about the posts... first... if negative for that one patient... how would it affect enrollment of those who might benefit? I can no longer find the posts... comments???

Question...

Entremed had about $21M remaining in the shelf registration... because the value is in dollars, it doesn't appear that this will be affected... comments???

It does make some sense that at least some of the Miikana shareholders will hang on for a runup in share price... that will depend on how they view the potential success of Enmd 2076...

The table on page 15 remains a puzzle... unless this is just a method of allocation of the milestone payment to the Miikana shareholders... but, it does presume that the shares will/can be sold as noted... and that is inclusive of all the SH on the table... sell... or not... remains to be seen...

Galt/George

I think George answered your question... i.e., not sure at all... my information comes from the table on page 15 of the S3 filing... and the last statement in George's e-mail...

It is quite confusing...

OK... I think I got it... the registration is for new stock which has been distributed to the original "Miikana Shareholders..." It appears that ENMD is acting as a broker to sell the stock at a public offering with the proceeds going to the original stockholders (OS)... the OS must pay for any fees, costs incurred in the sale...

Very confusing...

The proverbial "good news" is 1. this transaction will satisfy the milestone payment required by the start of the P2 trials(?); and, 2. without payment of cash or the use of the previous shelf registration of which $21M remains intact; and, 3. interestingly, not all of the OS have opted to sell all of the shares owned...eg, Queensland et al retains more that 2M shares and a 2.2% stake in Entremed...ditto with others...

Possible bad news is Novartis and Roche (both Vcapital funds - not the companies) disposed of all of their shares. and... Tak Mak and Gail Ekhardt, both Enmd connected researchers, disposed of 25% and 75% of their shares respectively...

Comments???

Hey VK... thanks for the quick response... what I am having trouble with is:

1. There is a list of current share holders who appear to be selling stock??? Is this new or existing stock?

2. Does this have any effect on the original shelf registration of which $21M remains...

Thanks again...

Very confusing... can anyone offer an interpretation/explanation of the "registration..."

good find George!

...the US team smears themselves with blueberries... george... for the most part... analogies are condescending... lol... go USA!

Hey Mobery

I was talking about my 12 years with ENMD.

Your question "If ENMD 2076 is such a great drug, why is it that it is such a big secret?"

I don't believe it is a secret... a couple of things... there are several companies and many AK inhibitors out there... and the interest is great... as a family they have demonstrated a unique potential for being effective... Gleevec being the clinical succsss story... so 2076 is not without competition...

Paul has poninted out that the planar characterisitics of 2076 may make it more structurally active... some have referred to it as a "best in class" AK inhibitor... the latter, of course, has yet to be proven...

So in a few words, most potential partners/investors are, most likely, taking a wait and see approach... you add to this some of the ENMD stumbles along the way with angio and endostatins, 2Me2/Panzem... there is, I suspect, caution being exhibited...

Interestingly, I am inclined to believe that the results with the a- & e- statins might be entirely different if clinical trials were conducted today... but, the cost of producing clinical material remains a high hurdle... and that plus the cost of the not very well considered bolus type dosing protocol nearly bankrupted Entremed...

At this point, I am opposed to a reverse split... if the current clinical trials demonstrate efficacy... delisting will not be a critical factor... and will be a temporary situation... and ENMD has stated they have the resources to complete the multi-site trials.

If the trials go south... then again... delisting will not matter...

Apparently... according to the noise on Yahoo, Motley Fool ran a teaser about Pfizer and Entremed in partnership talks... it is no longer on the site... curious...

At this point, I tend to agree... I think they should tough it out... what's another 5-6 months after 12 years?

Pfizer-Entremed talks???? Anybody???