Making money is never easy

I guess everyone agrees and there is no certainty in the stock market, especially in the biotech sector and worse in betting for a FDA decision! Unfortunately we got a real time example today with PTLA that I was expecting an approval yesterday. Instead, PTLA got a so-called complete response letter (CRL). In the biopharma jargon, a CRL means a non-approval decision, which will list what else the FDA is requesting for further consideration. One of the worse requests is new data that must be collected from clinical trials since such data will take years to provide. The CRL PTLA got seems not so bad as the key missing information is about some manufacturing issues and some details about the 2 anticoagulants that Andexxa is supposed to counteract. Without knowing details, my guessing is that this kind of information can usually be provided fairly soon. Given that the FDA did not question its efficacy and safety, I think it virtually told PTLA that this drug is approvable but just need a bit more time. Personally I think this gives another better opportunity to speculate on PTLA. We certainly will know more after PTLA meets with the FDA but I bet it will be positive to move the stock up from the current depressing level.  

As I said, I used a combo option setup to hedge my risk and it really works well as today’s 20% plunge did not hurt me at all. I will use this opportunity to go long again for PTLA as I think we now have a better chance to win this time.  Actually today’s price action for PTLA is quite impressive and positive, suggesting the selling pressure may continue to go down from here, barring of course any unknown negative surprises emerge.