Theralase Technologies Inc. V.TLT

Impact of a FDA Breakthrough designation

[ScienceFirst]

Another example of the impact of a FDA Breakthrough designation.  For something that shrank tumors.  Not destroy!  And that was discriminating among patients (genetic profile).  Not us.

From 12$ in 2014, to 20$ in 2015 to 235$/share (8B$) in Jan. 2019.  The stock climbed on presentation of data at ASCO in June 2017 (Hey Gorf79 ... DATA ... do you get it?) from 45$ to 80$.  Then to 190$ mid-2018, then a pullback to 140$ end of December 2018 (shorted) before the takeover from Lilly @235$ (8B$).

LOXO 6 Years Stock Chart History 


And Gorf39 whines!  Poor guy!


Loxo Oncology drug gains FDA Breakthrough status

Sep. 6, 2018

Loxo Oncology, which is developing cancer treatments, announced this week that it had gained Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its Loxo-292 drug.

The Breakthrough classification aims to speed up the development and review of a drug intended to treat certain types of lung and thyroid cancers based on their genetic characteristics and that has already undergone extensive clinical testing.

Clinical progress has galvanized investor support for Loxo. At the American Society of Clinical Oncology’s June 2017 annual meeting, a doctor from Memorial Sloan Kettering Cancer announced larotrectinib significantly shrank tumors in 76% of patients participating in recent trials.

Lilly Announces Agreement To Acquire Loxo Oncology

January 7, 2019

INDIANAPOLIS and STAMFORD, Conn., 

• Acquisition will broaden the scope of Lilly's oncology portfolio into precision medicines through the addition of a marketed therapy and a pipeline of highly selective potential medicines for patients with genomically defined cancers.
• Loxo Oncology's pipeline includes LOXO-292, an oral RET inhibitor being studied across multiple tumor types, which recently was granted Breakthrough Therapy designation by the FDA and could launch in 2020.
• Loxo Oncology's Vitrakvi® (larotrectinib) is an oral TRK inhibitor developed and commercialized in collaboration with Bayer that was recently approved by the FDA.
• Lilly will commence a tender offer to acquire all outstanding shares of Loxo Oncology for a purchase price of $235.00 per share in cash, or approximately $8.0 billion.

[LaserStock29]

Has Theralase utilized it's fast track as to get a 'rolling review' and keep communications with FDA.. and get a BTD going and not wait to submit a full package at once.. where shareholders will look at an NR.saying  wait another 60 days until the AGM?   Has Theralase applied for a grant for covid 19.. usually these grants take a good bit of time.. aka terry fox grant.&

[Rumpl3StiltSkin]

Hey Lazer, Just an idea on my part but I think the COvid 19 grant would come from/through Public Health Canada, via a partnership/licensing of TLTs tech?  TLT does have FT and yes that should mean BTD will come easily. TLT doesn't have all the patient data they'd need for that, yet...

[LaserStock29]

Is there information on what is exactly required for BTD? And that's the point of Fast Track.... if we dont have all the data yet compiled.. THAT IS OK. you start the clock.. submit what you have as an OPEN FILE.. so you DO NOT submit the whole package as one set of data.. like a REGULAR Company with NO FAST TRACK.  There must be beneifts that are granted and differneces between

[Yajne]

Hey LS29, great to see you posting again, your common-sense posts are very relevant. I have also wondered for some time now if TLT has used the access to FDA that was a major benefit of FDA fast track designation. TLT has been silent on this. However, I agree with you that if they took proper advantage to establish a 'rolling review', even though patient numbers have not yet fully met BTD