I think everyone would agree with Stuie... we need to see progress from pre-clinical data on CellPryme and OmniCAR, along with any news related to PTX-100, especially on our FDA guidance meeting to revalue the company. One of our programs needs to break the silence! Its no good our CEO hiding along with OmniCAR and our SP being at the mercy of the NBI, I don't think.
Stuie did a reasonable job conveying his unique perspective and raised some really good points. Newsflow from either CP or OC will attract sentiment towards this story... we are well aware of that fact! The most promising tidbit for me was his comment about unlocking the value of CellPryme: "its kinda getting ready for the big time is my sense of it." That's been my sense, ever since our last few periodic reports.
U.S. FDA Approves Bristol Myers Squibb’s Breyanzi ® as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
This is despite the therapy coming with the box WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES
The FDA approved the commercialisation Breyanzi despite its safety profile and possible side effects. It's better than what's on the market in terms of effectiveness simply because treatment choices are limited.
PTX-100 as an orphan drug is in a similar opportunistic space. As for OmniCAR, it has the potential to address the safety issues that Car-T presents... just got to optimise it to its full potential! Likewise, CellPryme... could be undergoing investigation by third parties right now using cell types such as NK or dendritic cells. The results of the ongoing pre-clinical work will surely precede regulatory package submissions. If so, newsflow could commence at any time.
Bring on PTX-100.... molecule drugs are simpler to produce, cost less to develop and manufacture than CAR cell therapies. The other important point highlighted in our written presos is that treatments like PTX-100 with good safety profiles and minimal side effects save the health system money. T-cell Lymphoma is a rare disease with a small market share, but drugs in this area sell for high prices too. PTX-100 may not be an exciting therapy but doesn't have to be to unlock value for the company. So long as PTX is seen to progress its programs toward the clinic, licensing, and commercialisation, the market will acknowledge it, especially if the biotech sector continues to attract investors and traders. I'm keen to know what's happening with CellPryme.
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