David: re your earlier comment on Thymitaq not being a miracle drug.
I reviewed what I could find of the clinical trials (Phase II), and I think you are right. IMO it is a very harsh drug, in that it is administered in the hospital and has side effects on most patients, with dosage needing adjustments. Taking the drug is a risky and IMO potentially lifethreatening action for many patients because of its effects on the body. While this is scary, cancer chemotherapy is often very difficult on patients.
The drug was effective in many patients, but "cured" only a few. So it is not a golden bullet, IMO, but another tool. Also, by following up on just the small Phase II clinical trials with the most positive results, Agouron may be accidentally pursuing paths highlighted by random statistical fluctuations. This suggests a risk that the results from the Phase III trials will not support approval (unlikely in my opinion, but at least a remote possibility).
I think that the early results of the Phase III clinical trials may be the reason that the date for submission to the FDA was set back somewhat from what was earlier projected.
On the upside, the recently highlighted positive effects of the drug when used with radiation suggest at least a fallback position, and possibly an even more important (and much wider) use of the drug than the one originally intended. This would probably initially be an offlabel use, although Agouron is not the kind of outfit that would want that and will likely engage in prompt clinical trials.
Now all of the above is just my own opinion, and is presented just to allow any one who has better insight to educate me.
For those of you who will get mad at this possibly negative information (or misinformation) let me add that I presently have roughly half of my retirement accounts in AGPH stock (long). I know that divergent opinions are not treated gently here, but still would like to collect the facts to better evaluate the prospects for the company. |
