Replies to post #11980 on Cytodyn Inc (CYDY)

[WallStreetSTTA]

We would rocket to $2+

[trding]

Last year they announced BTD application on Jan 22, 2016 and said in the conference call on March 24, 2016 that BTD was not approved, granted it was about 60 days between the two, but they didn't say how long they knew the answer. Assuming they get the answer with the 60 days... If the answer is no, they may announce tomorrow after close or maybe not at all until a cc. If they answer is yes, I'm guessing they announce Monday and if Tuesday 9:30 comes and we have not heard anything, then imo the answer was probably no--with a less likely chance of a delay from FDA.


PR Jan 22, 2016
http://www.cytodyn.com/media/press-releases/detail/222/cytodyn-files-request-for-breakthrough-therapy-designation

From March 24th, 2016 cc,
http://seekingalpha.com/article/3960931-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-call-transcript?part=single

In regards to our application for Breakthrough Therapy Designation for PRO 140 for HIV, we received a response from FDA. The FDA indicated that the agency concurs with CytoDyn that treatment experience for patients who have developed resistance against prior HIV regimen meet the criteria for a serious or life-threatening disease or condition, which would warrant a Breakthrough Designation.

However, the FDA indicated that CytoDyn’s previous studies were not in the specific patient population that the Breakthrough Designation for PRO 140 was applied for. Therefore, CytoDyn needs data from that specific population that the Breakthrough Designation was applied for in order to be granted that Breakthrough Designation.

The company now could plan and to initiate a small study in HIV resistant patients to specifically address FDA’s comments.

Please keep in mind, our current combinational therapy Phase 3 and monotherapy Phase 3 trials are both in different populations than for which the Breakthrough Designation was applied. Again, this delay on Breakthrough Designation does not have any bearing in our two current trials, monotherapy and combinational therapy, and could be addressed if we do conduct a small trial in the specific patient population and submit to the agency the appropriate data.

[123boom]

I hope your wrong today.