Re: Cephalon and Treanda hype

[Guest guest]

Who can blame them for taking profit in company stock if the price

rises? The regulatory agencies, that's who, if the company pumped up

the stock price with heavy duty PR campaign, and then the senior

executives cashed in. The Street name for this is " pump & dump " , and

if proven, people can go to jail for it.

Please note, I said IF IT CAN BE PROVEN. By the way, the company

Cephelon (manufacturer of Treanda) has prior history for ethics

violations, in the way it marketed its other drugs. There is on file a

FDA warning letter to Cephalon, re misleading marketing of " Provigil " .

Comapny pleaded guilty to ethics violations and paid a big fine.

Larry.

======================

> Larry - I looked at the Baron's article - the guys are cashing in -

who can blame them for taking some profit if the stock rose? -

============

[Guest guest]

It is interesting - On the one hand, if you have a good new product, and the media get a hold of it, and make the price go up, one could argue that that's OK. I have several friends with small companies and when they started to do well the media found out, wrote them up, and they cashed in some of their chips.

On the other hand, if the owners purposely and artificially inflated the price, and then cashed out, that might be another story.

I wonder how one goes about determining these things.

Anyway, we're a medical discussion group so we should probably leave this subject.

The unusual thing, which is probably the eyebrow raiser, is that Bendamustine has been around and in use in Europe for many years. How Cephalon got into the game, and how they caught everybody's attention, including already giving TREANDA a certain status, would be significant.

I originally posted about it because I saw the hype and thought we might get a new bullet in our gun.

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[Guest guest]

Forgive me for giving this one just one more going over, but I have

watched the various conversations about this in all the CLL discussion

areas, and I wanted to make another observation.

There has obviously been lots of marketing going on over the last few

weeks, in conjunction with ASH, which is happening at the moment. I

am not convinced that it is just the marketing that has provided the

unexpected fiscal bonus for the company execs.

Prof Hamblin pointed out on the ACOR list that the clinical trial for

the US market, comparing " Treanda " with Chlorambucil, was done using a

suboptimal dose of chlorambucil. Perhaps I'm missing the point, but

that appears to mean that any trial results are artificially biased

towards " Treanda " right from the very start. (In exactly the same way

that Fludarabine became the drug of choice - a trial against a

suboptimal dose of chlorambucil)

My question is this - who set the trial protocols in the first place?

Surely not the company run by the execs who just made great big wads

of dosh because of a 'totally amazing and unexpected rise in share

prices'?

Allegedly.

Andy

[Guest guest]

Andy,

I believe, trial protocols are set up by pharmaceutical firms for their own drugs; however, in the US, these protocols are submitted to the FDA that may accept or reject them on various grounds. Hence, ultimately, it's the FDA's fault if an invalid trial protocol is allowed to be used.

Andy Gach

Re: Cephalon and Treanda hype

Forgive me for giving this one just one more going over, but I havewatched the various conversations about this in all the CLL discussionareas, and I wanted to make another observation.There has obviously been lots of marketing going on over the last fewweeks, in conjunction with ASH, which is happening at the moment. Iam not convinced that it is just the marketing that has provided theunexpected fiscal bonus for the company execs.Prof Hamblin pointed out on the ACOR list that the clinical trial forthe US market, comparing "Treanda" with Chlorambucil, was done using asuboptimal dose of chlorambucil. Perhaps I'm missing the point, butthat appears to mean that any trial results are artificially biasedtowards "Treanda" right from the very start. (In exactly the same waythat Fludarabine became the drug of choice - a trial against asuboptimal dose of chlorambucil)My question is this - who set the trial protocols in the first place?Surely not the company run by the execs who just made great big wadsof dosh because of a 'totally amazing and unexpected rise in shareprices'?Allegedly.Andy

[Guest guest]

second try

Given a broad definition of Chemotherapy as:

" Chemotherapy is the use of chemical substances to treat disease. In

its

modern-day use, it refers to cytotoxic drugs used to treat cancer or

the

combination of these drugs into a standardized treatment regimen. "

Lenalidomide and Alemtuzemab are cytotoxic so in my opinion they are

Chemotherapy.

Is the schism that is appearing in the CLL " expert community "

helpfull to

patients? I think not.

When I hear reports of one CLL expert calling another a " Terrible

Doctor "

and resigning as president of his particular " Consortium " . I worry.

I hear of another blaming a death on yet another " expert " .

Come on guys - this is not egos at dawn. We are people, sort it out.

sorry to be so blunt - I do not mean to offend, but something

is " Crook in Tallarook " as we say in Australia.

Steve Madden.