Was having a nice walk in the woods this morning giving me plenty of time to think about things and of course all things Spectrum (it was a long walk) and Inquisitive reminding us that there is a continuing Mitomycin shortage over the last 5 years. Having FDA break precedent in needing 2 successful studies for getting approval to me is a high hurdle. Once you break precedent for one drug you’ll need to do it for others. The FDA would need some justification for doing so and still argue that everybody else will need 2 successful studies for approval. If the drug is significantly better than current therapy or it meets an unmet medical need then I can see FDA accepting the data for approval hands down but I’m not so sure Spectrum can show that. In reading posts from Your Biggest, I don’t get the impression it’s an unmet medical need. Having a Mitomycin shortage could be another reason and an argument I would use with the FDA i.e. having another alternative. So what to do? Spectrums two 800 person studies failed separately but if you combined the data it would be statistically significant. If big Pharma ran these studies you know they would have the money and resources to power the studies to statistical significance i.e. two 1600 person studies and it would get approval.
What came to mind was Genentech’s Avastin getting approval for one of the indications it’s approved for (I think it was breast cancer but not completely sure since I’m not at my home computer where I have all this info) and was thinking how it might relate to SPPIs situation. Avastin was tentatively approved based on a Phase 2 study that showed several more months of PFS than standard of care and Genentech agreeing to do a Phase 3 study that confirmed efficacy. So it went on the market and used for years but it eventually had to be removed from the market after the Phase 3 study came up short but the point being it was able to get the drug to market years before the P3 study was completed.
How does this relate to Eoquin? We know that if big Pharma ran these studies with 1600 people each, Eoquin would be approved. Why can’t SPPI argue that it shows statistical significance if combined and there is a need for another drug due to shortage and if you tentatively approve our drug, we’ll run another P3 study to confirm combining our 2 studies was justified. The cost of another study is minor when you can get the drug used right away. The FDA will also know that if they don’t accept the current data, SPPI won’t bother with another study that will take 5 yrs or so.
This a scenario where everybody comes out ahead. The FDA gets another drug out in the market so it won’t have to worry about a shortage of mitomycin and Spectrum could start selling the drug next year concurrently with running their study.
great thread folks; as a layperson, i ask as follows: why cant sppi make life much easier for itself by taking both folotyn and belinostate and then partnering up with a big pharma for their further clinical studies and for the cost of nda process w/r to belinostat. let big pharma pay the majority of the costs and let sppi share some of the profits. secondly, why cant sppi partner up with big pharma as to apaziquone as well. sppi has worldwide rights, sppi has a seeming indication by fda that it is amenable to convening an advisory panel . the big pharma could pay the majority of the costs and big pharma would properly complete the newly requested fda phase 3 eoquine trial and the big pharma would ensure proper completion of the multiple instillation trials of eoquin and all sppi has to do is share profit. NOW big pharma gives you access to worldwide marketing and distribution and manufacturing as well. so,,,, whats so crazy about partnering with big pharma which will ensure that sppi becomes a modest sized fish in a pond full of big fish...........as opposed to sppi being a big fish in a small pond.............
the alternative is that yes sppi can do this alone and keep all the profits..........but it seems to me it would be easier and likely more likely to attain higher percentage of success stories.....if sppi had bigpharma partners. just wondering if this is an option for sppi. the net result in my analysis is that sppi would end up many many times larger market cap than sppi has today - even with a sharing of the profit. yes i share my profit but i get access to the worldwide pie. a slice of a big pie is just as good as two slices of a small pie ?? i dont know. just throwing it out there.
meanwhile= i think big pharma has made overtures and inquiries to sppi mgmt aka raj about prospect of selling sppi .
"i ask as follows: why cant sppi make life much easier for itself by taking both folotyn and belinostate and then partnering up with a big pharma for their further clinical studies and for the cost of nda process w/r to belinostat. let big pharma pay the majority of the costs and let sppi share some of the profits. secondly, why cant sppi partner up with big pharma as to apaziquone as well."
In my view, the more independent SPPI stays and the more drugs it owns with worldwide rights, the more valuable SPPI is to a Big Pharma buyer including a Japan buyer.
Partnering with various Big Pharma partners on a "one off" basis only complicates and devalues any acquistion value for SPPI.
SPPI is a cash flow generator with Fusilev. Brilliant. Fusilev can fund the entire pipeline. Partnering benefits SPPI from a cash savings standpoint short-term, but Big Pharma wants earnings. The more earnings SPPI keeps by retaining all drug rights and the more worldwide rights it locks up, the more valuable the company is to Big Pharma ultimately.
trueliesarereal, you're a very ignorant person. I am sure that when you walk you are preoccupied with which foot goes next and can't concentrate on anything else; hence, your inability to comprehend that antihama could actually gain such a very well thought out perspective while taking a walk. Do us all a favor and crawl back under your rock. See ya Slingblade.
Sentiment: Strong Buy
“Spectrum also announced that a scheduled meeting with the U.S. Food & Drug Administration (FDA) was held last month to discuss the results from the Company’s Phase 3 clinical trials. Based on the discussions with the FDA, Spectrum understands that the FDA can accept the NDA filing with the current Phase III data and will likely convene an Advisory Committee meeting. Further, based on discussions with the FDA, SPECTRUM HAS AGREED TO CONDUCT ONE ADDITIONAL PHASE III STUDY following consultation with the FDA on its design.”
Did I call it or what!!! Sorry about touting my own horn here but I am ecstatic! Jumping for joy! Doing cartwheels! WuWhoing! Grinning! Hey, back in early November, I told you guys that I sent this idea about doing another study and getting interim approval to SPPI and Allergan but did not hear a peep from them. I think I’ll demand consultant fees! Sorry for all the exclamation points!!!
Yes, Antihama, I repeatedly mentioned the possibility too as a "best case scenario". You have to remember, though, this is a process. Nothing is approved. They mentioned the possibility of a "review committee" and that review committee still might not vote in favor. The facts as we know them are: APAZ is NOT dead and is back in strong play once again..Yes, an interim approval would be awesome...icing on the cake....Analysts better start re-factoring in some potential serious valuation expansion here.....
As I recall, the FDA earlier this year did approve a diet pill based on pooled data. Also, several months ago, the FDA modified policy so as to get newer,and more effective drugs to patients whose chances of survival would increase if such drugs were used in early stages of cancer.
Also, there has been no new treatment for bladder cancer in over 20 years. Current treatment is far more toxic than Apaziquone and generally could be viewed as management, not curative.
To the best of my knowledge, bladder cancer generally reoccurs within three years. Consequently, surgery is repeated and another 10 instillations are given. At this point, the patient has had 20 instillations of a radioactive substance which harms other organs, still does not destroy all of the original cancer, and may result in a new cancer emerging possibly due to the amount of radiation exposure. It is not uncommon for such patients to ultimately require surgical removal of the bladder.
If this is the predictable prognosis for patients with bladder cancer, I personally believe that if Apaziquone can be equally or more effective with one instillation, it must be approved. If a patient has one additional instillation every year and remains cancer free with no damage to other organs or need for additional surgery for ten or more years, Apaziquone comes close to being a drug to meet an unmet medical need. IMO. Even if not approved, it would be my drug of choice.
that all sounds good. but pk says it won't happen and we know his nearly perfect prediction record when it comes to all things sppi. so.......it must be a slam dunk approval!!!! haha. sorry pk, but most of us know you are paid to bash here.
if we were a deep pocketed large pharma i do believe we would get approval since after their FDA career, many of those guys are rewarded with a nice big pharma job. i think the safety of E would help the decision because at least they know they would not be putting a drug out there that would be killing people or making them severely ill, unlike many other drugs they have put on the market in the past.