Mega Drug close to FDA approval on May 28 ..I See $1.50-2 on Approval Day...
After years of development and clinical trials, the NDA final step is nearing an end with the PDUFA of May 28. All the hard work and sacrifice is looking to pay off in a big way in 2014.
Most shareholders are in this at a much higher level than the current price. Everyone knows there is a big event coming soon (FDA decision) and an approval from the FDA will be huge for this stock.
Testosterone is a well characterized molecule, thus the regulatory requirements for approval are less stringent than a typical NCE (new chemical element).
Topical gels are primarily used to treat Low "T" in the US and run the risk of transference to family members. Thus, all of the products have black box warnings. If approved, CompleoTRT has a much lower risk of transference and is unlikely to have the warning. This distinguishing characteristic should aid in marketing efforts once approved.
The US Testosterone market is very large and relatively untapped. The US market is currently valued at $2 Billion and growing despite only about 10% of addressable men currently treated.
The top selling low "T" drug is Androgel which had a staggering $1.373 Billion in sales over the past 4 quarters, in the US alone !
This stock is tightly held with First Generation Capital and other insiders holding more than half the shares.
RBC Capital Markets gives the stock an Outperform rating with a 12 month target of $1.50. I think this is low. I could see TRL over $2.00 with an FDA approval of Compleo and the naming of a good partner.
On top of all this, Tefina (which is the equivalent of female viagara) with blockbuster potential, is nicely developing in the wings.
Lots to like here with the FDA to make a decision by May 28.
I was right on NWBO, ACAD, ARNA, ... I know the pharma industry and you can bet that Pfizer will buy them out on the condition of FDA approval of Compleo and positive phase 2 results on Tefina (which will be made public this month as well). I agree with you for the spike toward $1.75-2/share. I expect the buyout offering at a 40% premium, so around 2.5-3 dollar/share. So my advice is sell at spike around $1.75-2/share and buy back afterwarts around $1.10-1.20/share , because buyout will happen.
I am interested that you mention Pfizer buying out Trimel. Pfizer is my partner of choice for Tefina - who better to market a 'Female Viagra' than the Pharma who brought us Viagra? Cannot wait to see the ads! My partner of choice for Compleo is AbbVee. They have the lions share of the topical market already and Compleo's advantages could help meet upcoming oral competition. Compleo's post P3 marketing data showed 70% of those who previously used other topicals would switch to Compleo. A Takeover is always a possibility. Exciting week.expected.