Smart scan

Point it at a matter: it detects document types, builds the chronology, and lists every party. Live.

Smart scan / 1018-00005

Penterra Pharmaceuticals Corp Real Estate 12 docs · open →

Document types detected

Correspondence4

Analysis / memo4

Engagement letter2

Other2

Parties across the matter

Callendar Baines Group LLCCorporate Secretary Penterra Pharmaceuticals CorpDatabase Callendar Baines Group LLCGrange LLPHARKNESS LLPHarkness LLPPediatric Exclusivity IncPenterra Pharmaceuticals Corp

Chronology

2023-12-01 · dormancy-confirmation-letter.docx

… rs are regularly confirmed. This matter will be reviewed on or before December 1, 2023, and annually thereafter for so long as it remains in dormant status. If the Firm does no …

2022-12-06 · dormancy-confirmation-letter.docx

… LLP 1120 Avenue of the Americas, 32nd Floor New York, New York 10036 December 6, 2022 VIA EMAIL Lisa Moritani, Esq. General Counsel & Corporate Secretary Penterra Pharmaceutic …

2022-12-01 · dormancy-confirmation-letter.docx

… is letter confirms our receipt and acknowledgment of your email dated December 1, 2022, in which you instructed Calderwood & Harkness LLP (the "Firm") to place the Velonatib ch …

2022-12-01 · email-client-hold-dormancy-notice.eml

… ngagement under Matter No. 1018-00005 as **dormant** effective today, December 1, 2022. No further work should be performed on the draft USPI, Medication Guide, REMS assessment …

2022-12-01 · file-preservation-dormancy-memo.docx

… Penterra Pharmaceuticals Corp. ("Penterra" or "PPC"), by email dated December 1, 2022, Matter No. 1018-00005 is hereby placed on dormant status effective December 1, 2022. The …

2022-11-30 · dormancy-confirmation-letter.docx

… ing the active phase of the engagement — spanning from July 7 through November 30, 2022 — have been preserved in both physical and electronic form. These files will be maintaine …

2022-11-30 · email-client-hold-dormancy-notice.eml

… 4. **3. Billing Confirmation.** We confirm that all invoices through November 30, 2022 — totaling $287,450 in fees — have been paid in full. No further invoices should be submi …

2022-11-30 · file-preservation-dormancy-memo.docx

… keepers assigned to this matter should close their time entries as of November 30, 2022, and should not enter any additional time against matter number 1018-00005. Any inquiries …

2022-11-28 · dormancy-confirmation-letter.docx

… 3, 2022 • Post-CLARION-3 Regulatory Path Analysis Memorandum, dated November 28, 2022 • FDA Type B Meeting Briefing Document (Calderwood & Harkness review comments), dated Ap …

2022-11-28 · email-client-hold-dormancy-notice.eml

… the thorough post-CLARION-3 regulatory path analysis memorandum dated November 28, 2022. We have discussed the options you outlined with Dr. Anand Raghavan and the senior leader …

2022-11-28 · file-preservation-dormancy-memo.docx

… The Post-CLARION-3 Regulatory Path Analysis memorandum (Item 9, dated November 28, 2022) provides a detailed assessment of the implications of these results. CLARION-3R (Phase I …

2022-11-22 · dormancy-confirmation-letter.docx

… er 20, 2022. Both of these deliverables were placed on formal hold on November 22, 2022, following the release of the CLARION-3 top-line results and Penterra's subsequent decisi …

2022-11-22 · draft-medication-guide-psoriasis-rev2.docx

… ssion. ⸻ FORMAL HOLD NOTICE ⸻ THIS DRAFT WAS PLACED ON FORMAL HOLD ON NOVEMBER 22, 2022, FOLLOWING THE CLARION-3 TOP-LINE RESULTS. NO FURTHER REVISIONS WILL BE MADE UNTIL THE EN …

2022-11-22 · file-preservation-dormancy-memo.docx

… (Principal Consultant). Both documents were placed on hold effective November 22, 2022, at the direction of Dr. Hessler following the announcement of the CLARION-3 top-line res …

2022-11-21 · post-clarion3-regulatory-path-memo.docx

… forth herein incorporates feedback and direction received during the November 21, 2022 working group call among Penterra Regulatory Affairs (Dr. Karen Hessler and her team), Ca …

2022-11-17 · file-preservation-dormancy-memo.docx

… eek 16. Top-line results from CLARION-3 were announced by Penterra on November 17, 2022. The trial did not achieve statistical significance on the PASI-90 co-primary endpoint, w …

2022-11-17 · post-clarion3-regulatory-path-memo.docx

… ne results of the CLARION-3 Phase III confirmatory trial announced on November 17, 2022. The analysis set forth herein incorporates feedback and direction received during the No …

2022-10-20 · dormancy-confirmation-letter.docx

… October 15, 2022; and • Draft Medication Guide Update, Rev. 2, dated October 20, 2022. Both of these deliverables were placed on formal hold on November 22, 2022, following th …

2022-10-20 · email-clarion3-results-impact.eml

… ev. 3 (dated October 15, 2022) and the Medication Guide Rev. 2 (dated October 20, 2022). No further development, revision, or review of the sNDA submission package is warranted …

2022-10-20 · draft-medication-guide-psoriasis-rev2.docx

… r oral use NDA No. 215-847 — sNDA (Psoriasis Indication) Revision 2 — October 20, 2022 Prepared by: Christopher Aiken, Associate Calderwood & Harkness LLP Reviewed by: Sean Mor …

2022-10-20 · rems-assessment-memo.docx

… y associated labeling changes. Draft Medication Guide Rev. 2 is dated October 20, 2022, and is currently under internal review within Penterra Regulatory Affairs. Patient Packa …

2022-10-15 · dormancy-confirmation-letter.docx

… ed the following: • Draft USPI — Psoriasis Indication, Rev. 3, dated October 15, 2022; and • Draft Medication Guide Update, Rev. 2, dated October 20, 2022. Both of these deli …

2022-10-15 · email-clarion3-results-impact.eml

… n hold immediately. This includes specifically the USPI Rev. 3 (dated October 15, 2022) and the Medication Guide Rev. 2 (dated October 20, 2022). No further development, revisi …

2022-10-15 · email-patent-counsel-labeling-coordination.eml

… **Timing and Logistics** We are targeting completion of Rev. 3 by **October 15, 2022**, and would appreciate W&G's comments by **October 12** if at all possible. The draft is …

2022-10-15 · draft-medication-guide-psoriasis-rev2.docx

… ion Guide is being prepared in parallel with Draft USPI Rev. 3 (dated October 15, 2022) and is intended to be fully consistent with the proposed USPI language. Any discrepancie …

2022-10-15 · draft-uspi-psoriasis-rev3.docx

… r oral use NDA No. 215-847 — sNDA (Psoriasis Indication) Revision 3 — October 15, 2022 Prepared by: Sean Morrissey & Christopher Aiken, Calderwood & Harkness LLP Reviewed by: J …

2022-10-12 · draft-uspi-psoriasis-rev3.docx

… (W&G) dated October 3, 2022. W&G review is targeted for completion by October 12, 2022. This item is tracked as Open Item #2.] 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosag …

2022-10-03 · dormancy-confirmation-letter.docx

… rding labeling language and Orange Book listing considerations, dated October 3, 2022 • Post-CLARION-3 Regulatory Path Analysis Memorandum, dated November 28, 2022 • FDA Typ …

2022-10-03 · draft-uspi-psoriasis-rev3.docx

… ail coordination between S. Morrissey (C&H) and B. Takata (W&G) dated October 3, 2022. W&G review is targeted for completion by October 12, 2022. This item is tracked as Open …

2022-10-01 · regulatory-strategy-memo-velonatib-psoriasis.docx

… g User Fee Act, as most recently reauthorized by PDUFA VII (effective October 1, 2022), the standard review clock for an efficacy supplement is ten months from the filing date …

2022-09-28 · draft-medication-guide-psoriasis-rev2.docx

… Comments. This Rev. 2 incorporates comments received on Rev. 1 (dated September 28, 2022) from the following Penterra reviewers: • Dr. Karen Hessler, Senior Vice President, Regu …

2022-09-22 · dormancy-confirmation-letter.docx

… orandum, dated September 8, 2022 • REMS Assessment Memorandum, dated September 22, 2022 • Draft USPI — Psoriasis Indication, Rev. 3, dated October 15, 2022 — DRAFT, ON HOLD • …

2022-09-08 · dormancy-confirmation-letter.docx

… ugust 12, 2022 • Pediatric Study Deferral Analysis Memorandum, dated September 8, 2022 • REMS Assessment Memorandum, dated September 22, 2022 • Draft USPI — Psoriasis Indicat …

2022-08-12 · dormancy-confirmation-letter.docx

… t Letter, dated July 7, 2022 • Regulatory Strategy Memorandum, dated August 12, 2022 • Pediatric Study Deferral Analysis Memorandum, dated September 8, 2022 • REMS Assessme …

2022-08-12 · file-preservation-dormancy-memo.docx

… e psoriasis market. The regulatory strategy memorandum (Item 2, dated August 12, 2022) provides a detailed analysis of the competitive landscape, regulatory pathway, and strat …

2022-07-28 · draft-medication-guide-psoriasis-rev2.docx

… ra obtained a deferral of the pediatric studies, which was granted on July 28, 2022, with a deadline of 18 months post-adult approval. If pediatric data become available bef …

2022-07-28 · pediatric-deferral-analysis-memo.docx

… in adults who are candidates for systemic therapy or phototherapy. On July 28, 2022, FDA granted Penterra's request for a deferral of the pediatric study completion deadline …

2022-07-07 · dormancy-confirmation-letter.docx

… e not limited to, the following: • Executed Engagement Letter, dated July 7, 2022 • Regulatory Strategy Memorandum, dated August 12, 2022 • Pediatric Study Deferral Anal …

2022-07-07 · engagement-letter-penterra-snda.docx

… LLP 1120 Avenue of the Americas, 32nd Floor New York, New York 10036 July 7, 2022 VIA EMAIL AND FIRST-CLASS MAIL Lisa Moritani, Esq. General Counsel & Corporate Secretary …

2022-07-07 · file-preservation-dormancy-memo.docx

… the Firm's representation of Penterra in this matter was executed on July 7, 2022, by Joel Strauss on behalf of the Firm and countersigned by Lisa Moritani on behalf of Pe …