thanks doc for your insights.
I request you to answer my questions little more specifically if possible. Or let me re-word them:
1. Can we come to know for sure that necrosis is happening without doing a de-bulking surgery?
2. The tumor mass was increasing despite of a CR, what if we have more such patients? Do they all have to go through surgery to figure out?
I read this case report (you can google the title and read it if you have not)
"Albumin-Linked Doxorubicin (Aldoxorubicin) as Treatment for Relapsed
Glioblastoma: A Case Report"
from the report:
'We report here a patient who appeared to experience tumor progression after treatment with aldoxorubicin by
both clinical and radiological assessments'
The authors call it pseudo-progression. I think neither CytRx, nor invetigators were going to know about the necrosis unless a de-bulking surgery was not done because from radiological assessment , the tumor in-fact was getting bigger in size.
Q1. So I wonder what happens if we have some more patients with tumor size increasing in radiographic scans but yet not so big to mandate a surgery? How they will be able to know whether necrosis is happening?
Q2. How is the necrosis beneficial if the tumor size keeps increasing (though through pseudo-progression) leading to another surgery?
Thoughtful answers and discussions are welcome. I saw 2-3 posters in past few days who appear to be physicians, MD, oncologist etc. so I think they might be able to answer my question.
it has been up +60% YTD even before Oppy said anything.
You can relate today's gain to Oppy's coverage initiation but I doubt they know anything beyond what we know about GBM trial through CytRx
hnic65, thanks for your insights
CytRx detected the presence of aldoxorubicin in Kaposi Sarcoma patient samples which I believe was a very strong validation and indication of Aldo penetrating and working. Also some KS patients had tumors in lungs and those patients too responded well , that info should bode very well for the ongoing Phase 2 NSCLC trial.
I have one complaint: I had a email conversation with David Haen and I was sadly surprised to find that they didn't analyze the necrotic tumor ( that was removed from the patient who had the CR ) for presence of aldoxorubicin which could have validated the BBB cross in humans straight away.
Anyways, it seems to be worth the wait.
i would like to share my thoughts on this
In US, drug companies are not given 'data exclusivity', so whatever data an approved drug has, can be used by other company to make a generic version or an improved version. So drugs are protected by patents and by no means you can cover/claim all the data as a patent claim.
In EU, the situation is different. Data Exclusivity prevents other companies from referencing the original safety and efficacy data for a generic or improved version.
In conclusion, CNCE should have more freedom to operate with d-ivacaftor in US than in EU
Buying out the competitor or locking in the competitor is a well known and time tested strategy.
However, it depends on the competitor's situation, whether it is badly in need of a deal or not.
CNCE guys should be knowing this very well, but to build investors confidence, they had to do some deals with big names (look at the terms of the deals, not so attractive for CNCE). Few such deals and after that they can own rest of the pipeline with 100% ownership of their assets.
Thanks for sharing.
Its too early, will be entering phase 2 while CYTR is moving towards completion of P3. Big difference.
No deal value is mentioned, doesn't sound like a threat at this point.
are you nuts?
Read my question again.
Buyout rumor came yesterday and not when this was $3.02
No big pop why?
FYI, i am long SGYP