TELESTA THERAPEUTICS INC T.TST

of value to non TST bagholders and brought here

[princeofcut]

again by me and not them.
HT for you, in an ealier post (attacked as always by the TST bagholders) i indicated a benchmark biotech going for FDA approval on a similar timeline as TST and with similar skinny data....

...after the close today and before the 60 day deadline they received notification from the FDA of not only acceptance but of their file but also granting them a priority review...this is why i kept correcting on your posting on this issue...i wonder if TST will hear from the FDA before the end of the week?? and this is IMO encouraging for TST..

..and again this is useful information brought to this MB by me and please id any value the TST bagholders have provided????

[simouuun]

Printz, I quoted before: The RPM notifies the applicant of a priority review designation in writing by day-60, or of a standard review by day-74.  So we could get the info about PV until this friday...  https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffPoliciesandProcedures/ucm082000.pdf

[princeofcut]

simon, thanks for the clarification, it is what i thought it was before getting bogged down in this cesspool..to me simple 60 days in or out, IMO as MCNA is 2nd line oncology it is priority or out..i've only owned oncology centric stocks and for them it was 60 days RTF or priority review...i suspect the cause of HT's and TST bagholder confusion was the TST webcast and presentation this

[simouuun]

"MCNA is 2nd line oncology it is priority or out" - why? Explain that. I believe that the FDA will grant PV, but if not, i don't think, this means the end for MCNA....  

[princeofcut]

simon, please read page 1 of the doc you linked under background and elsewhere, it is what i always thought priority review was for and tell me is this where MCNA belongs or not...IMO regular review is for like arthritis cream, etc. but oncology is as best i know almost always priority...i could be wrong but that is my interpretation and IMO so long as no RTF all is good

[FarmaBoy]

Ah sry I was replying while you were mate. To your point: it is not the case that all cancer drugs get priority approval, but mostcancer drugs start off 3L or 4L therapies, then work forward (see Roche's Pertuzumab trial readout and filing timeline as a nice case study) However, this is not the case with TST, so for the reasons in my other replynfew minutes ago, I do think you are probably

[FarmaBoy]

Hmm, I'd imagine he means the following: There is no such thing as a low priority 2L oncology filing (and lets face it, if approved this will be used off label 1L too - FDA will be aware of this) So, the logic goes that if the filing will be accepted, this almost automatically will mean priority status too. Doesn't make standard review impossible, just the less likely option, given