Exactly, that's the question.....Is it possible to figure that one out. While I look forward to responses from others, let me relate recent biopharma experiences. Now, if the reader is one of those who has drank the Kool-Aid, and wants to hear only pie-in-the-sky proclamations, do us both a favor and stop reading now.
I started stocks just a few months ago. My academic background is biochemistry, but I don't work in biopharma. My introduction to pharma was with Discovery Labs (DSCO) and the PDUFA for Surfaxin. After a weekend of digging-up and reading tech papers, FDA Tracker reports, "pump" articles in Seeking Alpha, etc. I called for APPROVAL. This was contrary to FDA Tracker and Adam Feuerstein's panel of experts voted CRL also (albeit by just one vote). Surfaxin was approved. The stock price had risen steadily for the previous few months, and was at about 3.60 when the halt was called. I had 3000 shares at 3.57. Announcement came just after market close and SP immediately shot over 6 bucks. I could have then doubled my money, but held. It was my first PDUFA experience and I was on cloud nine. The next morning management held a conference call, at the end of which a major stock dilution was revealed. SP plummeted. I was lecturing. I sold for just a $400 gain....Coulda had 9K. DSCO is now trading at 2.40....Over a buck below SP at time of halt. If I had held long I'd now be down about $3200.....For making the right call.
After doing not much DD on KERX, I called CRL for KRX-0401 (Perifosine). PDUFA was CRL.
Alexza's quest for approval of Adasuve (Staccato Loxapine) is the most interesting to me. Feuerstein said too close to call , but his "guess" would be CRL. For me this was tougher than DSCO or KERX, but I called for APPROVAL. ALXA got a CRL. Here's the key thing: CRL was due to a recent FDA onsite inspection of Alexza's manufacturing facility, and not part of the public record. Alexza previously had to lay-off most of it's staff due to tight finances. I conjecture the inspectors found concerns about proper hygiene and sterile environment. So, I was correct about the drug itself, but suffered a CRL all the same. I still made $$. Held 12,900 shares at 0.54. SP was consistently around 0.60 until 2 days prior to PDUFA. Day before PDUFA SP went to 0.78, then started down. I sold 2/3 of my position at 0.74 and held the rest. During the afternoon, SP was knocked down to 0.58. After CRL SP went to 0.36 in AH, but climbed to 0.51 the day after, where I sold my remaining 1/3. Now at about 0.40.
If you're still with me, check-out the 3 month chart for PLX and match it with the PDUFA date of May 1st. Yeah, May 1st, and the drug was APPROVED!! Amazing. I wasn't in on this one.
Respectfully submitted,
SciGuy
