Haven't said anything here since that post. Now we know that AEZS has Perifosine back, we've seen the data from the Phase III Colon Cancer trial and know there's little hope with Stage 4 patients, except one specific group which may benefit. We've also seen new data supporting why the MM Trial should continue.
I think if there is one word that describes where things stand, it's delay. The NDA for AEZS-130 is delayed for discussions with the FDA. The Phase III Trial for AEZS-108 is delayed until the companion diagnostic can be used. The first peek at the MM trial for Perifosine is apparently delayed by patients living longer, though I cannot confirm that.
The good news IMHO is these delays are for the right reasons. Management isn't collapsing under the weight of investors demands into doing something quickly, rather than doing it right, and doing it well. Investors may say that management isn't communicating this well, the fact is they've laid it all out for anyone listening. Not only have they spelled out why things are delayed, they've also said they'll do partnerships when they believe the time is right, not be rushed into them.
To me it's clear that AEZS-130 won't be partnered until initial findings have been seen in the Cancer Cachexia trial. This trial could really be a game changer for this drug, not that the drug won't be approved for HGH deficiency testing, but because that's a niche market, cachexia could make this drug have blockbuster potential. Would you partner it before you knew what you had? Some would. Let's say that for HGH alone a partner would pay $10 million up front, but with cachexia unknown they'd pay $25 million, some would say take the $25 million, and probably moderate royalty numbers. On the other hand, if you wait several months and some cachexia patients stop losing weight, and perhaps start gaining, you'll know it's effective, is it possible you'll see $100 million or more in the partnership, and substantially higher royalty figures, I believe it is. I believe it's a trial worth waiting for.
It's also clear that AEZS-108 won't partner until Phase III starts. AEZS won't have someone else dictate terms of how the trial's to be constructed, perhaps they learned a lesson with KERX. The fact that the diagnostic should improve on results previously achieved while reducing trial costs makes it worth the delay. If a big name Pharma comes along with a general partnership for the entire world, they have sufficient funds to run whatever trials they wish, but they'll complete the one that AEZS initiates, which should lead to initial approval.
There is so much pipeline potential in this stock it's amazing. We're valuing each drug at pennies when each and every one of them could eventually add $$$$'s to the price of the stock.
Gary |
