Thursday, October 6, 2011

$PLX : Volatility Squeeze, looking for the break out

$PLX Technically looks very interesting, the Bollinger bands became horizental and very close to each one, (Volatility Squeeze) and we can see a very clear positive divergence in both the MACD and the RSI, beside the expansion of the volume during the up days and contraction in the down days, give us the clue of accumulation.

Protalix have a several catalyst, First, the PDUFA date on 02/01/2012, but have major catalyst during this period, as the company have to reply to the EMA (Europe) 120 day question and will be submitted during October as the IR told me last week, the management took a long time to reply to EMA 120 day question from April, I think it was smart and safer move to synchronize EMA data with FDA data.

After PLX submits the 120 day questions – EMA has 2 months to review and then comes back to PLX with a second set of questions (called 180 day questions as it's 180 days from filling).  Protalix then responds and should hear shortly after that on a recommendation by CHMP.  
The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicines for human use.
Notice of formal approval would then follow the CHMP recommendation (assuming positive). and can be done during Dec 2011 or early Jan 2012.

Third catalyst is the Brazilian approval that could happened at any time (very close).

Fourth Catalyst is the Investigational New Drug (IND) Application for phase I/II clinical trial in Fabry disease will be submitted before the end of the year as noted by the CFO Mr. Yossi Maimon at Jefferies & Co. Global Healthcare Conference-UK, held on September 27, 2011, he mentioned that the FDA encourage PLX to submit an IND for phase I/II directly in's bio better product.

For the safest trade, start position after breaking out the upper Bollinger band.

Disclosure: Long $PLX

Daily Chart

1 comment:

  1. Just get reply from IR, will reply to the EMA 120 days question very shortly, will not PR this event.
    The Company was focused first on getting FDA resubmission in, then on EU questions.
    Working closely with Pfizer.