RE:RE:RE:RE:It takes money to advance oncology R&D
enriquesuave wrote: So far no calls. I can confirm I invested in last PP after a phone call. For sure they will need money by latest end of May. How it will come is anyone's guess. If they submitted BTD request then we may soon get an answer. Regardless of whether they are waiting on more data to submit, or already have done so, I think that they can at anytime update FDA on new data which will give the FDA more info for the path they need to take for AA. If the FDA has access to more data at the time of BTD submission then while they are deep in analyzing it, they can decide to grant AA or at least give a path( such as 10 or 20 more patients at 450 days or whatever). Regardless, they will get updates. All IMO. I think there is enough data now, but we shall soon find out.
I agree...I think we are closer than many realize to qualifying for an accelerated approval (AA), especially when you consider we would be providing additional interim data re: clinical efficacy as opposed to providing just surrogate endpoint data.
There has been a growing cost for AA drugs & many states/Medicaid officials are putting increased pressure on the Feds to redefine coverage inclusion criteria (I.e. excluding/denying coverage of AA drugs if they demonstrate a lack of sufficient evidence of clinical efficacy...something a surrogate endpoint doesn't directly address).
It is reassuring to know our Ph 2 study is based on clinical efficacy endpoints & that the data thus far is demonstrating a significant advantage over available therapies (in interim efficacy, low number of treatments/low treatment burden, safety, etc...), & we are presenting an option that is not only patient-friendly, but also cost-friendly, which should put big smiles on the faces of both state & federal officials. All imo...