Caly,
While this certainly was unexpectedly bad news, it's my belief that the stock dramatically overreacted to it considering the strength of its pipeline and ongoing trial and drug approval efforts. I've more than doubled my position since the fall and am looking forward being well over break even before the end of the year.
Currently it's my belief that Perifosine has been written off by most investors, so should KERX not maintain the Phase III Trial for MM, the stock will hardly be affected. On the other hand if that trial's sustained, I believe both AEZS and KERX will see upside potential, especially when approaching the end of the trial. Investors may be cautious, once burned, but if the trial continues, and if the data's good, the stock could easily be $5 or more after the top line data's been announced.
Without that data, things move more slowly. I listened to yesterdays presentation and it appears that Phase III for AEZS-108 will be started much later this year, the diagnostic which better determines who's most suitable for the drug should be available prior to its start. AEZS-130's NDA submission will come this year, but again they don't seem to be rushing it, and frankly it's better to have it done well then be done quickly. It's acceptance could easily come after sufficient data exists on Cancer Cachexia to determine it's worthy of a Phase III Trial, or not, but if it is, practically from approval it will be used off label which could make sales of the drug greater than anticipated. Of course I don't expect AEZS to keep this drug world wide, waiting for at least preliminary Cachexia data could greatly increase it's value in a partnership. I don't believe we'll see a partnership for the drug until at least the first preliminary data has been seen, but it's very possible the NDA filing will come before then.
In the webcast the company also indicated they wanted Phase III to at least be initiated before engaging in partnership discussions. While I frankly don't know that it's worth far more after the start of a trial, in that everything is blinded, but by waiting, AEZS will have total control of the trial design. Once a partnership is established, the partner might speed the trial by adding more trial centers, they might even develop other trials for other indications, but they'll have no influence into the design of the trial. I frankly like the confidence being shown by the company, however yesterday's webcast was a rather nervious and weak presentation by our CEO who was working with slides in English, which I believe is his second language, he often stuttered and had to excuse himself. That said, I'm in for the science, not for the speeches by the CEO, however I frankly think some presentations could be better made by others at the company.
It would be nice if we had some others speaking up here.
Gary |
