There is a new presentation on the company website dated 8/1/2013. I am still reading it, but it is interesting.
My first impression is that they are making an effort to be more realistic with their timelines.
Melphalan - complete enrollment by year end 2013 - primary endpoint is 100 days - they hope to file NDA end of 2014, which would be up against my 6 month NDA filing yardstick.
Apaziquone - NDA in 2015. This should allow for enough time to enroll and treat all patients, and get several interim milestones on progress, plus a 6 month span to file.
I am still reading more details on Apaz and the drugs in Ph2 and Ph3.
Astro, Thanks for the information. IMO, this is the smartest change they can make. Recently, we were told a NDA for Belinostat was being submitted to the FDA on June 15. Then, with no explanation, we learn next year or end of this year. That disappoints and angers investors. It happens so often, it looks dishonest.
People tend to remember negatives for a long time. Consequently, a realistic timeline must be given and be met. This must be done until it is considered reliable.
If Spectrum is going to succeed, trust is mandatory. Without it, no one will believe good news no matter how glowing it may be. This company should also be more realistic about how successful drugs are or will be. When we are told about how great a drug is, then see sales at $4 million every quarter, who does not become skeptical? (OT) And when will they replace Shiv Kapoor? He sounds as though he is most pleasant and helpful, but what are his qualifications and what does he do? Does this company employ anyone to handle PR and/or advertising? More press releases to keep investors informed mitigates the sense of being kept in the dark about bad news. Advertising and PR, both would be an improvement compared to the SA slop we see. Showing investors that they are appreciated and respected is never a bad idea.
This is ALL B.S . Don't believe anything these guys say. They said Fusilev will grow and 3 weeks later came back and reduced guidance from growth to decline of 50%.....Remember the wicked ceo who was selling his shares while SHAMELESSLY going to investor conferences and pumping fusilev outlook and stating fusilev sales will sustain. BAD APPLES
After researching a bit on clinical trials I have a bit of a skeleton timeline.
File Belinostat NDA - Dec-2013
Complete enrollment of Melphalan study Dec-2013
Primary endpoint of Melphalan study - 100 days - April-2014
Possible results from small Marqibo study Jan-2014
Process results and file NDA for Melphalan Dec-2014 to Mar-2015
Would need to start enrolling in new Apaz study reasonably early 2014 so as to complete enrollment and have preliminary results to support an NDA filing at any time in 2015, even Dec.
SPI-1620 Ph2 study #1 Primary endpoint - Nov-2014
SPI-2012 Ph2 study Primary endpoint - Dec-2014
SPI-1620 Ph2 study #2 Primary endpoint - Jul-2015
File Apaziquone NDA - Dec-2015 (corp pres just said 2015, so I picked the end of the year)
Marqibo label expansion Ph3 study #1 Primary endpoint - Dec-2015
Marqibo label expansion Ph3 study #2 Primary endpoint - Jul-2015
I have not found the Zev-DLBCL study yet in clinical trials so I don't have an anticipated date for it.
You forgot Ozarelix: Primary completion date of phase 2 is Sep 2013. It is 214 patient study. The results of Marqibo phase 2 study in uveal melanoma could be announced soon since the study completion date is July 2013.
Belinostat in PTCL if approved will be tough to sell. It will compete against istodax which is already on the market and generates revenue in PTCL. Both belinostat and istodax belong to the same class of drugs, HDAC inhibitors. Safety profile could help, but the advantage is not proven by head-to-head clinical study.
astro - concerning the timeline I highly doubt Belinostat will be filed in Dec 2013 or EVER unless the payout to Topo is changed.
Reason being that odds of Belinostat approval are low so it would be a waste of $$$ by SPPI to file the NDA.
IF SPPI can get Topo to alter the deal (so SPPI does not have to give Topo shares & $ for filing) then sure! Why not ! But now ??? No way, IMO
Apaz is the key for longs now, IMO. Belinostat most likely never makes it to market.
Another thought regarding the revised Apaziquone NDA of 2015 is that it makes Allergan's decision much more understandable. It possible that Allergan expected any path forward would be this lengthy and still not a sure thing, whereas as a smaller biotech, SPPI would likely have been optimistic they could reach an agreement sooner.
On a similar note I understand even a loser company like Avanir was eventually able to conduct a follow-up study and get approved for a product that actually had safety issues. So I am still confident that Apaz works and can gain approval, what this delay means for market share is something I cannot assess at this time, but a potentially 2-year delay will affect my sales forecasts.