Tom P. writes, "Recent communications between the FDA and Delcath Systems ( DCTH) have persuaded me that the FDA is likely to approve ChemoSat in June. The stock plunged when Delcath did not get priority review, but Delcath said in a largely ignored press release that the FDA had told them that in the long run, the standard review period would be better for them. ... Today, the FDA told Delcath that it would be best for them if they limited their New Drug Application to liver cancer stemming from ocular melanoma, as there is no other effective treatment available and it constitutes an unmet need. Unmet need equals 100% advisory panel vote which equals FDA approval." Tom, I appreciate you trying to make lemonade from a lemon (Delcath), but your drink is still too sour. I agree ChemoSat does stand a decent chance of receiving FDA approval next June, although it's not 100% guaranteed. The more important issue you overlook is that the ChemoSat label, if granted, will be marginalized into near irrelevance from a commercial perspective. On Wednesday, Delcath disclosed an amendment to the ChemoSat NDA narrowing the proposed indication to treatment of patients with liver metastases stemming from ocular melanoma only. Dropped from consideration were patients with liver metastases from cutaneous melanoma.
Will writes, "What do you think of Teva's ( TEVA) recent investment in Galena Biopharma's ( GALE) NeuVax? I am a Teva long, and all that I know about Galena is from your articles, so it sounds like it's not very promising. But what do you think Teva's business-development people see in NeuVax and what are the detailed terms of this deal? Is it really a bona fide investment/partnership on Teva's part? Or is it basically like a lottery ticket for them tied only to a small region (Israel) where Galena would get tiny royalties if it ever worked out? Based on how much risk is taken on, sometimes these deals reflect a very limited interest in the molecule by the partner, and sometimes a very strong interest. I don't know how to judge them."