Accelerated Approval for RECCE® 327, page-82

Hey Catterbox thanks for the post and lets hope both our gambles pay off
I'm wondering how you've determined that the approval is years away conceding the process has already started and also being fast tracked? I'm not saying your incorrect but RECCE 327 drug trial per patient would be extremely short imo as it is for treating bacterial infections. I would think this would occur over days or weeks (worst case) per patient. Not months or years of trials and data collecting to monitor possible changes within patients. I agree for sure that many drugs need to be tested over very long periods of time before a real indication of effectiveness in treating particular illness is known but I don't think RECCE 327 is in the same category. I think this is why they are fast tracking and will likely use surrogate endpoints from pre clinical test rather full blown human trials. I think reading over the FDA web site and watching interviews with FDA Commissioner Scott Gottlieb RECCE 372 certainly seems to meet the criteria for using surrogate endpoints as a means to approve quickly with a commitment form RCE to conduct larger human trials within 3-5 years of the approval of RECCE 327. My understanding is fast track approval for RECEE 327 could be as soon as six months. Please I am interested to know if you have found anything to contradict this. I admit for sure it is difficult to get any exact timelines from FDA however it is clear that RECCE 327 is being view by the FDA as filling an unmet medical need (FDA wording not mine).

Possibly when RCE decide to pursue RECCE 327 for it's cancer treatment potential it will take years before results are know. I think this is why they decided to postpone the FDA approval process for this and focus on treatment for bacteria as it was always going to be quicker to get to market. Also if it is already approved I would assume it could be prescribed for any illness should doctors decide it maybe effective. I'm not suggesting this would occur overnight but if trials are underway and results are know to be promising then I don't see why it couldn't be prescribed by doctors. I'm sure they prescribe drugs all the time that were developed for one illness but used on many different illnesses.

Thanks and sorry if above is poorly written, I'm tired
Baldy