Oncolytics Biotech Inc T.ONC

RE:RE:RE:RE:How does Accelerated Approval work

[Noteable]

RE:RE:RE:RE:How does Accelerated Approval work

And for those who don't read or understand what has already been posted  ... 

this was posted on Apr 15, 2024 2:38pm

In the case of Orphan / Rare diseases and in diseases with unmet treatment needs, the FDA appears to have a tendency to grant  drug Accelerated Approvals much quicker than otherwise, and they do so in an overall effort to drive patients suffering from these diseases into the registration studies earlier than could happen normally. 

 

By ONCY beginning the process of enrolling between 180-200 patients in a monotherapy pelareorep + paclitaxel clinical/registration study ONCY speeds up the Accelerated Approval process by demonstrating to the FDA that ONCY is well into the implementation of a well designed clinical study, with FDA agreed upon primary and secondary endpoints, that have resulted in previous Accelerated Approvals, as exemplified by Pfizer's Paloma and Daichii's Destiny successes. 

Now there is room for one or two with 2 and potentially 3 registration studies to be pursued both in monotherapy and in combination with other I/O agents. The monotherapy registration study offers ONCY the freedom to operate and removes any restriction for the company to partner with one Big Pharma company or another.

 An Accelerated Approval results in the creation of a revenue stream for ONCY and an accretive asset for any Big Pharma acquirer of ONCY.  And because of this capital opportunity eventually happening, I think that the latter Big Pharma acquisition will happen sooner than later and well before an Accelerated Approval is even announced. 

RE:RE:RE:Kirk Look to speak today

Look said this - " ... What we presented to the FDA was a Phase 2 concept, kind of using the receipe that's been used [before], you know, quite a few times. Ibrance is a good example in HER2 as well as a good example of how a Phase 2 the size of 180-200 patients can be powered in a manner that if you reach cerftain endpoints, that the powering is sufficient to seek accelerated approval with the promise of [the Phase 2 study turning into] a confirmatory study ..."

Kirk Look also said the following - " ... we are on the cusp of the (Bracelet-1) overall survival (OS) data. We will expect that to be announced imminently .  ... "