Robert Schwartz

Robert Schwartz
Contributor since: 2012
Company: RHS Advisors, LLC
I believed in Yervoy and provoked its licensing by BMY. Same story with nivolumab.
As an aside, William Coley did cure patients with metastatic sarcoma with Coley's toxin; he also killed quite a few. Immunotherapy does work under select circumstances.
Not all, I continue to believe that trial will fail.
A well-written and researched assessment.
The Sunrise trial is comparing Bavituximab + docetaxel vs. docetaxel and, as I mentioned previously, there are NO RANDOMIZED data available to portend success. That is why the "drug" hasn't been scooped up by big pharma and why the stock is trading at levels of LOW anticipation.
The only hope for Bavituximab is one of BMY's immune stimulants and I would characterize that as a "long shot".
The trial will fail.
Thanks Pete, will try and find the time.
It's early but I readily acknowledge my miss on AVEO!
I am still a GALE bear and haven't yet done diligence assessments on IMUC or NW.
They have certainly had a good run of late!
My advice was that investors throw in the towel. PPHM will not throw in the towel until the goose stops producing their salaries.
Their data doesn't merit a BTD.
Excellent summary!
Patrick is usually correct when making PTRS predictions so perhaps I was overly optimistic,
Thanks for the question. The 15-20% number refers to the probability of a successful Phase-III outcome and I still stand by this number.
Regards,
Robert
The FDA will expedite approval of drugs with the so-called "Breakthrough Designation". The designation does not obviate the need to conduct studies that demonstrate the effectiveness of the drug.
I said that a large, well-powered study would have been required for PPHM to have garnered an SPA for Bavi. The elected not to do the study recommended by FDA and the approval of Bavi (assuming a positive Phase III trial) will be a review issue.
I good sized study is necessary to "tease out" the differential activity of the Bavi combination.
Robert
A large well powered study would have gotten them an SPA.
Truffle,
A company is free to conduct any study they choose to register a drug and it is up to the FDA to determine if the data from that trial supports registration.
Recently, companies looking to eliminate some of the risk of their registrational trials have sought agreement from the FDA (under a Special Protocol Assessment or SPA) on trial design and an outcomes that would confer an approval. Note, however, that there was NO mention of an SPA in PPHM's press release which implies that the results from the trial will be determine during FDA's review. One must conclude that PPHM and FDA could not agree on terms and conditions for an SPA. This action supports my skepticism.
PPHMstockofcentury,
The answer is no to both questions. I have no hidden agenda; I simply call it as I see it.
Robert
Indeed I was, a humbling experience!
FDA asked the Advisory to consider whether a second trial is necessary and this drove Aveo's share price lower. I continue to believe that the current body of data will support approval but I am increasingly in the minority. I think a reasonable outcome would be to grant tivo a "conditional" approval with full approval contingent on a second study. If I were Aveo, I would use placebo as the comparator in the second study (per the Axitinib and other agents).
Who said anything about allovectin working??? I do not believe that it does.
R
He obviously meant IL-2
....... and so was CLSN.
Jsibel720,
No, we've never met.
Robert Schwartz
Thank you; lets hope for the best possible outcome.
Patrick,
I am familiar of the prosecution history; if the drug becomes successful the generics will let the their dogs out...as I believe you are suggesting.
In addition, I have concerns about prior art for which there is a significant volume. With a bit of digging the patents could possibly be overturned on an Inequitable Conduct ruling (speculation).
Wall,
I am quite uncomfortable with their patent situation; their may be some serious "obviousness" issues
Wall Street,
It depends on the data and a partner's tolerence to risk. I will check out a few comparables.
Partnering the asset after showing a PFS (only) benefit in STS will not initially net them a big deal with a large upfront payment; the partner will want to back-end load the payments to coincide with specific risk events (e.g., positive SCLC trial). That said, a small deal could become a large deal if they manage to brink home the goods in the other indications.
If survival benefits were realized in both STS and SCLC, the asset would be worth some bucks (safety is important as well).
The other important deal elements are the potential synergies with the partner's pipeline and sales and marketing infrastructure.
Pete,
If palifosfamide is successful, it will provide the revenue to develop the gene therapy.
Robert
I am a bit late to this article but felt compelled to acknowledge your effort; nicely done!
Robert Schwartz