Replies to post #77137 on Biotech Values

[DewDiligence]

Welcome back! I appreciate your blurbs on various happenings in the pharma/biotech universe. Regards, Dew

[DewDiligence]

Housekeeping Note re iHub’s Favorites Page

i've been doing a manual search for 'biotech values' in the search box. but now i've added it to favorites and bookmarked it.

All regular and occasional readers of the board should use iHub’s Favorites page to access the board—it’s much faster than arriving at the board by searching in the search box or navigating iHub’s Boards menu.

Reminder: To add this board to your iHub Favorites page, go to the main screen for this board that lists the latest messages and click on the link that says Add to Favorites. This link resides immediately above the horizontal blue bar that marks the top of the list of messages. (If the link says Remove from Favorites, then this board is already on your Favorites page.)

Once this board has been added to your Favorites page, you may access the board from anywhere on iHub by clicking the Favorites link near the top of every iHub screen.

i noticed that the board isn't available on the Biotech NASDAQ list anymore. did you guys move?

The board was recently moved to the User’s Groups category for technical reasons that have no consequence to posters and readers. Regards, Dew

[srsmgja]

Pharmaclown - thanks for the update from the AAN. I have a few questions, if you would care to answer.

Cladribine -

A cytotoxic drug that interferes with DNA synthesis and repair. Has been linked to cancer to more than one paper.

If you asked a dozen medical experts regarding their perceived safety issues BEFORE a two year trial I would guess that one of the primary issues would be cancer risk.

So what did we find in the trials? Cancers - Approx 5/800 in Cladribine versus 0/400 in placebo.

Now if you asked that same panel of experts, based on the phase 3 trial results, are we likely to see an escalating number of cancer cases as one doses Cladribine (again, a cytotoxic drug) over more and more years? I would guess that many would say yes, or at a minimum show considerable concern.


Based on the above, why would you think that the FDA would consider placing Cladribine on the market AT THIS TIME, without additional study? Based on only 1 phase 3 trial.

Notice that I have not even addressed the teratogenic risk, or the fact that the trial just barely hit stat. significance in 'reduction of disability progression'.

TIA