Listen to the call a gain. Did you hear him use the term a REAL "breakthrough"?? I did, and I think he was USING that term in a VERY pointed way. Given the issues with Opioids, this could be a real potential for NKTR 181. Means we could get to market much FASTER.
Check out PCYC, and their price action after receiving BREAKTHROUGH status.
For those not familiar,
"One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.
According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency. "We expect many of these would come available very quickly with Phase I data," she said.
So far, we know that Vertex ($VRTX) has won breakthrough status for two drugs for cystic fibrosis, the approved drug Kalydeco and the experimental VX-809, now being studied as a combination therapy. According to Woodcock, a third drug has been anointed with the special status. And developers have submitted 18 for review, most of which are for cancer"
Cowen Group presentation this morning (3/5/13) , with regard to NKTR - 181, he used "Ground Breaking & Game changing"… Hmm, "ground Breaking" well if you break the ground, you are "BREAKING THROUGH" the ground. Very cute, and careful, but a "breakthrough drug is a breakthrough drug", and as NKTR-181 develops, they will pursue, WITHOUT QUESTION. Also, interestingly, he spent a significant % of the presentation on NKTR-181, they are excited about this one!
NKTR-181 has not been designated breakthrough by the FDA, although it has been fast tracked. HR would be screaming it from the rooftops if it was. What you heard was HR in salesman mode. And the existing opioids are real competition. No patient will stick with NKTR-181 if it isn't effective against their individual pain.
We have a HORRENDOUS opioid epidemic, and FDA/DEA/medical community is beside themselves looking for a solution. HR did NOT say he "had breakthrough" status. HE SAID, this is a, "REAL BREAKTHROUGH". There is no way he has not heard of the "breakthrough" designation, and I believe he KNOWS exactly what he was saying, AND was dropping a GREAT hint. They will pursue this, and we could be on the market MUCH FASTER. :-)
..No patient will stick with NKTR-181 if it isn't effective against their individual pain. .
True, but physicians in pain treatment are desperate for an alternative to existing opiods simply because a large percent of their patients are just drug seekers.. so therefore.. who's gonna write for Opana or Oxycontin or Lortab when their is a viable option.. Md's are no longer naive to the opiod addiction problem (they were in the past) as USA has a current epidemic on hand..
What happened to Zohydro?? shot down.
Look at whats going on now for new FDA programs for drug deterrents and restrictions..
The US and ROW needs anew pain medication with LESS addiction, abuse and safety issues.. not none.. just a less more manageable drug.. the bar is set relatively low for 181 imo.
So.. 181 only gets 1/3 of the long acting pain market priced at a premium.. how many bills$ a year would that fetch?