Tuesday, August 30, 2016 10:27:44 AM
1.) Ibalizumab has no side effects and no drug interactions. I am not sure why you think otherwise as there is no evidence to suggest that.
2.) Ibalizumab could well be a monotherapy some time in the future. Taimed's strategy has been to start at the low end of the market and work up. They have plans for a once per month version that could conceivably be utilized as a monotherapy but I doubt they would go that route, but instead would pair it with at least one other drug in testing as that is the normal approach in HIV clinical trials. Basically, CYDY has had a very bad clinical strategy to developing PRO 140 and it is costing them. Taimed has a very sensible strategy and that is why they are in the enviable position they are in. CYDY is still struggling to figure out the clinical path forward as all the struggles with the FDA indicate.
3.) Both PRO 140 and Ibalizumab work very well. Ibalizumab covers the whole HIV marketplace and PRO 140 only a portion. PRO 140 requires an expensive and time consuming tropism test while Ibalizumab does not (since it covers all HIV patients). That has been a problem for CYDY in terms of the cost of testing and the ability to find patients for its study. It is also why the company has been trying to get away from doing tropism tests but the FDA will not let them. IT is a big issue for them.
4.) Ibalizumab will initially hit the market as a once every two week IV but within a year will likely be available in a once every two week injection. The simply need to do a bioequivalence trial, which will take roughly six months and then wait for the FDA to approve it (assuming it shows bioequivalence which seems highly likely).
5.) Many here seem to be vastly underestimating the financing challenge facing CYDY. Its current balance sheet is a disaster with the massive number of warrants. They may be able to continue to find adequate financing via unconventional means but it will certainly be something that should keep current CYDY shareholders awake at night until they pull something off. It is going to be quite a while before CYDY has any phase III test results and longer still before the drug gets to the market and starts generating revenues, so there is a lot of money yet to be raised. The best bet for shareholders would be for CYDY to sell the rights to a well funded company and start working on its next project.
Both drugs work, but Ibalizumab has several key advantages and will have more as time passes. That is one of the benefits of being first to market, you can continue to improve your product while competitors work just to get on the market. Like you said, PRO 140 can still play a role in the HIV market but it has yet to demonstrate it has a clinical pathway to success. PRO 140 might make you a millionaire, but you will likely need to be a buyer of the stock after its last dilutionary stock offering before it starts generating revenues. While the current management team is certainly trying to find the right pathway to the market, the company's struggles with the FDA are a clear indication this is not an easy task. Still, since the drug works, one has to assume it will eventually find a way to help people. So, it is indeed possible that both drugs will one day be on the market and not really competing head to head.
Recent CYDY News
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:06 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 09/07/2024 12:44:56 AM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/07/2024 12:42:22 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/15/2024 09:21:30 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/22/2024 01:00:58 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:17:48 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 07/09/2024 09:16:28 PM
- Form SC TO-I/A - Tender offer statement by Issuer: [Amend] • Edgar (US Regulatory) • 07/09/2024 09:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 12:46:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 09:15:10 PM
- Form SC TO-I - Tender offer statement by Issuer • Edgar (US Regulatory) • 06/03/2024 09:10:56 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:17:30 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 09:09:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/09/2024 02:30:20 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:16:47 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/01/2024 10:15:34 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/22/2024 10:16:11 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/16/2024 02:00:24 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/12/2024 10:31:57 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/29/2024 10:22:17 PM
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