perifosine....fda will ask for additional information and it will eventually be approved in the first half of 2013, but in the interim the stock will take it on the chin as a result and also with the extra added bonus of further dilution later in 2012 and the timing of which will really suck for current shareholders. year end 2012 price $2.75.
What you say is certainly possible, the FDA has delayed many drugs that everyone looking at them said would be approved, but over time we were right, they did approve the drug. It's sad, but if KERX isn't bought out, as they've openly indicated they desired, they'll be fighting an FDA bias against the tiny biotechs.
I believe there are two ways of viewing the FDA's bias. One is that the FDA is largely funded by big Pharma, so it is biased toward big Pharma. The other is that small Biotech's with limited resources simply don't have the skills in preparing NDA's and therefore leave questions unanswered. What's sad is that great drugs are often delayed by questions which could easily be answered either in Phase IV's, an approval granted that had time limitations which would be removed when the questions were answered.
My first investment in biotechs involved Genentech's first drug, TPA as I remember it. I purchase some slightly out of the money calls looking to make a killing on its approval. There were no doubts about the effectiveness of the drug, but rather than approve it, the FDA asked a question that was never a part of the trial protocol involving it's long term benefits. Just the question insured a 6 months delay, but the answer took even longer, I'm uncertain just how long approval was delayed, but my options were worthless, the stock tanked, and while I should have bought then, I never did. Genentech went on to become one of Biotech's greatest successes, and of course now is wholly owned by Roche.
I would feel far better about Perifosine being approved on initial FDA approach if KERX is bought out before the NDA is filed. I believe the data will prove worthy of approval, but when filing a NDA, not only does every I have to be dotted and T be crossed, but questions that were never previously asked may need to be answered. By the way, no matter how many questions you answer, if the FDA doesn't want to approve a drug, they can always find something to ask. Such is the power of G-d's like Dr. Padzur.
it's unfortunate, but due to the reasons you cite I think it's easier to make money shorting small bio/pharma after a news related price rise then it is to make money being long waiting for that news, as it undermines the efforts of many truly dedicated health care professionals to bring lifesaving advancements to patients in dire need.
perifosine...KERX refers to event 360 in future tense at the JPMorgan presentation. Monitoring the event rate, KERX/AEZS deduces the unblinding event will not occur in time to release top line data in 1Q12.
Facing investor concerns, they advise they will issue statement and preliminary results at event 360. AEZS price slowly rises to 3.50
On March 12th, they release 360 event with raw data demonstrating a median 4.5 month OS advantage, price rises to 4.50.
July 22nd FDA approves NDA stock price 6.25.
August 15th Roche offers 9.25 which is rejected. AEZS pipeline produces 3 way bidding war with Roche, Merck and Bristol-Meyers Squibb not only for Perifosine but because of their pipeline.
Dec 14th I will sell all my stock at the frenzied bidding price of 97.28 only to find out that those darned Mayans were right afterall and the world is going to end in a week anyway. Dang it.
Maybe I should just stick with paragraph 1&2.
I will add that it wont be the end of the world. We will all be transformed into a higher intelligence and money will not be needed. We will be able to materialize what we want. "ask and it shall be given"
Or we will be annihilated by the coming mayan catastrophe